The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, or until the Registration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.

The information in this preliminary prospectus is not complete and may be changed. The Selling SecurityholdersWe may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and it is not soliciting an offeroffers to buy these securities in any state or jurisdiction where the offer or sale is not permitted.

18,682,812

19,342,359 Shares of Common Stock

Pre-funded Warrants to Purchase Shares of Common Stock

Series A and Series B Warrants to Purchase up to 19,342,359 Shares of Common Stock

GUARDION HEALTH SCIENCES, INC.Shares of Common Stock Underlying the Pre-Funded Warrants

19,342,359 Shares of Common Stock Underlying the Warrants

This prospectus relates to the sale by the selling securityholders named in this prospectus (the “Selling Securityholders”) of

Guardion Health Sciences, Inc. (the “Company”, “GHS”, “we”, “us” or “Guardion”“our”) 17,260,312is offering 19,342,359 shares of common stock, par value $0.001 per share, of the Company and (i) Series A warrants to purchase shares of common stock (the “Series A Warrants”) and (ii) Series B warrants to purchase shares of common stock (the “Series B Warrants,” and collectively with the Series A Warrants, the “Warrants”) (and the shares of common stock that are issuable from time to time upon exercise of the Warrants). We will issue Warrants exercisable into an aggregate of 19,342,359 shares of common stock in this offering. Series B Warrants will only be issued to the extent we do not have sufficient authorized shares to permit the immediate exercise in full of Warrants to purchase 100% of the number of shares of common stock being offered in this offering.

We are also offering to each purchaser whose purchase of shares of common stock in this offering would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the holder, 9.99%) of our outstanding common stock immediately following the consummation of this offering, the opportunity to purchase, if the purchaser so chooses, pre-funded warrants to purchase common stock (the “Pre-Funded Warrants”), in lieu of shares of common stock. Each Pre-Funded Warrant will be exercisable for one share of our common stock.

The purchase price of each Pre-Funded Warrant will equal the price per share at which the shares of common stock are being sold to the public in this offering, minus $0.01, and 1,422,500the exercise price of each Pre-Funded Warrant will be $0.01 per share. This prospectus also relates to the shares of common stock issuable upon exercise of common stock purchase warrants.We will not receive any of the proceeds from the sale by the Selling Securityholders of such securities.However,Pre-Funded Warrants sold in this offering. For each Pre-Funded Warrant that we will receive proceeds from the exercise of the warrants if they are exercised for cash by the Selling Securityholders.

The Selling Securityholders may sell, the number of shares of common stock describedthat we are offering will be decreased on a one-for-one basis. Each share of common stock and Pre-Funded Warrant is being sold together with Warrants exercisable into an aggregate of one share of common stock. Each Warrant will have an exercise price of $           per full share. Series B Warrants will only be issued to the extent we do not have sufficient authorized shares to permit the immediate exercise in full of Warrants to purchase 100% of the number of shares of common stock being offered in this prospectus in a number of different ways and at varying prices. We provide more information about how a Selling Securityholder may sell itsoffering. Because we will issue Warrants to purchase 19,342,359 shares of common stock in this offering, the section titled “Plannumber of Distribution”Warrants sold in this offering will not change as a result of a change in the mix of the shares of our common stock and Pre-Funded Warrants sold. The Series A Warrants will be exercisable immediately and will expire five (5) years from the date of issuance. The Series B Warrants become exercisable only after we have effectuated a Charter Amendment (as defined herein), and will expire five (5) years from the date they first become exercisable. The shares of common stock or Pre-Funded Warrants, and the accompanying Warrants, can only be purchased together in this offering but will be issued separately and will be immediately separable upon issuance.

Our common stock is listed on page 78. We intend to apply to listThe Nasdaq Capital Market (“Nasdaq”) under the symbol “GHSI.” The last reported sale price for our common stock on NYSE American underNasdaq on October 23, 2019 was $0.517 per share. The actual number of securities, and the symbols “GHSI” or “GRD” if available. No assurance can be given that our applicationoffering price per share of common stock, Pre-Funded Warrant and accompanying Warrants, and the exercise price for the accompanying Warrants, will be approved or thatas determined between us and the underwriters at the time of pricing, and may be at a discount to the current market price. Therefore, the recent market price used throughout this prospectus may not be indicative of the actual public offering price for our common stock and for the Pre-Funded Warrants. The assumed public offering price is $0.507 per share of common stock (based on the closing price of our common stock on the Nasdaq on October 23, 2019) and $0.01 per accompanying Warrants and $0.497 per Pre-Funded Warrant and $0.01 per accompanying Warrants. There is no established public trading market for the Pre-Funded Warrants or the Warrants, and we do not expect a market to develop. In addition, we do not intend to apply for a listing of the Pre-Funded Warrants or the Warrants on any national securities exchange. Without an active trading market, the liquidity of the Pre-Funded Warrants and Warrants will ever develop.be limited.

The Selling Securityholders and any broker-dealers that participate in the distribution of the securities may be deemed to be “underwriters” as that term is defined in Section 2(a)(11) of the Securities Act of 1933, as amended.

We are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 and may elect to comply with certain reduced public company reporting requirements. See the section titled “Implications of Being an Emerging Growth Company.”

Investing in our common stock is highly speculative andsecurities involves a high degree of risk. You should carefully consider the risks and uncertainties described under the headingSee “Risk Factors” beginning on page 148 of this prospectus.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.

We have also granted an option to the underwriters to purchase up to 2,901,353 additional shares of common stock (to the extent such shares are available for issuance) and/or Warrants on the same terms and conditions set forth above from us within 45 days after the date of this prospectus before making a decision to purchase our common stock.cover over-allotments, if any.

NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED OF THESE SECURITIES OR PASSED UPON THE ACCURACY OR ADEQUACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.The underwriters expect to deliver the Company’s securities to the purchasers on or about         , 2019.

The date of this prospectus is, 2017.2019.

ABOUT THIS PROSPECTUS

In this prospectus, unless the context suggests otherwise, unless otherwise noted, references to “the Company,” “GHS,” “we,” “us,” and “our” refer to Guardion Health Sciences, Inc. and its consolidated subsidiaries.

This prospectus describes the specific details regarding this offering, and the terms and conditions of the common stocksecurities being offered hereby and the risks of investing in our common stock.the Company’s securities. You should read this prospectus, any free writing prospectus and the additional information about usthe Company described in the section entitled ‘‘Where“Where You Can Find More Information’’Information” before making your investment decision.

Neither we,the Company, nor any of ourits officers, directors, agents, representatives or underwriters, make any representation to you about the legality of an investment in ourthe Company’s common stock. You should not interpret the contents of this prospectus or any free writing prospectus to be legal, business, investment or tax advice. You should consult with your own advisors for that type of advice and consult with them about the legal, tax, business, financial and other issues that you should consider before investing in ourthe Company’s common stock.

ADDITIONAL INFORMATION

You should rely only on the information contained or incorporated by reference in this prospectus and in any accompanying prospectus supplement. No one has been authorized to provide you with different or additional information. The shares of common stock are not being offered in any jurisdiction where the offer is not permitted. You should not assume that the information in this prospectus or any prospectus supplement is accurate as of any date other than the date on the front of such documents.

TRADEMARKS AND TRADE NAMES

This prospectus includes trademarks whichthat are protected under applicable intellectual property laws and are ourthe Company’s property or the property of ourone of the Company’s subsidiaries. This prospectus also contains trademarks, service marks, trade names and/or copyrights of other companies, which are the property of their respective owners. Solely for convenience, trademarks and trade names referred to in this prospectus may appear without the ® or TM symbols, but such references are not intended to indicate, in any way, that wethe Company will not assert, to the fullest extent under applicable law, ourits rights or the right of the applicable licensor to these trademarks and trade names.

INDUSTRY AND MARKET DATA

Unless otherwise indicated, information contained in this prospectus concerning ourthe Company’s industry and the markets in which we operate,it operates, including market position and market opportunity, is based on information from our management’s estimates, as well as from industry publications and research, surveys and studies conducted by third parties. The third-party sources from which we havethe Company has obtained information generally state that the information contained therein has been obtained from sources believed to be reliable, but wethe Company cannot assure you that this information is accurate or complete. We haveThe Company has not independently verified any of the data from third-party sources nor have wehas it verified the underlying economic assumptions relied upon by those third parties. Similarly, internal company surveys, industry forecasts and market research, which we believethe Company believes to be reliable, based upon management’s knowledge of the industry, have not been verified by any independent sources. OurThe Company’s internal company surveys are based on data we haveit has collected over the past several years, which we believeit believes to be reliable. Management estimates are derived from publicly available information, ourits knowledge of ourthe industry, and assumptions based on such information and knowledge, which we believemanagement believes to be reasonable and appropriate. However, assumptions and estimates of ourthe Company’s future performance, and the future performance of ourits industry, are subject to numerous known and unknown risks and uncertainties, including those described under the heading “Risk Factors” in this prospectus and those described elsewhere in this prospectus, and the other documents we filethe Company files with the Securities and Exchange Commission, or SEC, from time to time. These and other important factors could result in ourits estimates and assumptions being materially different from future results. You should read the information contained in or incorporated by reference into, this prospectus completely and with the understanding that future results may be materially different and worse from what we expect.the Company expects. See the information included under the heading “Forward-Looking Statements.”

REVERSE STOCK SPLIT

On January 30, 2019, the Company filed a Certificate of Amendment to its Certificate of Incorporation, as amended, with the Secretary of State of the State of Delaware to effectuate a one-for-two (1:2) reverse stock split (the “Reverse Stock Split”) of its common stock without any change to its par value. All share and per share numbers in this prospectus reflect proportional adjustments for the Reverse Stock Split which adjustments were made to the Company’s outstanding common stock, stock options, and warrants as if the split occurred at the beginning of the earliest period presented in this prospectus.

TABLE OF CONTENTS

PROSPECTUS SUMMARY

The following summary highlights information contained elsewhere in this prospectus. This summary may not contain all of the information that may be important to you. You should read this entire prospectus carefully, including the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and ourthe Company’s historical financial statements and related notes included elsewhere in this prospectus and incorporated hereby by reference.prospectus. In this prospectus, unless otherwise noted, the terms “the Company,” “GHS,” “we,” “us,” and “our” refer to Guardion Health Sciences, Inc. and its consolidated subsidiaries.

The Company

Overview

Guardion Health Sciences, Inc. (the “Company”) was formed in December 2009 in California as a limited liability company under the name P4L Health Sciences, LLC. The Company changed its name to Guardion Health Sciences, LLC in December 2009. On June 30, 2015, the Company converted from a California limited liability company to a Delaware corporation, and changed its name to Guardion Health Sciences, Inc.

The Company is a specialty health sciences company formed to develop, formulate and distribute condition-specific medical foods with an initial medical food product on the market under the brand name Lumega-Z^®Lumega-Z® that replenishesis designed to replenish and restoresrestore the macular protective pigment. A depleted macular protective pigment is a modifiable risk factor for retina basedretina-based diseases such as age-related macular degeneration (“AMD”), computer vision syndrome (“CVS”) and diabetic retinopathy. The Company believes this risk may be modified by taking Lumega-Z to maintain a healthy macular protective pigment. Additional research has also shown a depleted macular protective pigment to be a biomarker for neurodegenerative diseases such as Alzheimer’s disease and dementia.

In September 2017, the Company, through its wholly-owned subsidiary VectorVision Ocular Health, Inc., acquired substantially all of the assets and certain liabilities of VectorVision, Inc., a company that specializes in the standardization of contrast sensitivity, glare sensitivity, low contrast acuity, and early treatment diabetic retinopathy study (“ETDRS”) visual acuity testing. VectorVision’s standardization system is designed to provide the practitioner or researcher with the ability to delineate very small changes in visual capability, either as compared to the population or from visit to visit. VectorVision develops, manufactures and sells equipment and supplies for standardized vision testing for use by eye doctors in clinical trials, for real-world vision evaluation, and industrial vision testing. The acquisition expands the Company’s technical portfolio. The Company believes the acquisition of VectorVision, through which it added the CSV-1000 and ESV-3000 to its product portfolio, further establishes its position at the forefront of early detection, intervention and monitoring of a range of eye diseases. The Company has had limited commercial operations to date,date. Until recently with the acquisition of VectorVision and development of the Company’s sales force, the Company has primarily been engaged in research, development, commercialization, and development.capital raising. On September 3, 2019, the Company announced that it completed development of its new proprietary CSV-2000 standardized contrast sensitivity test. The Company believes that the CSV-2000 is the only computer-generated vision testing instrument available that will provide the optical marketplace with the Company’s proprietary, industry-standard contrast sensitivity test, along with a full suite of standard vision testing protocols. The proprietary standardization methodology incorporated into the CSV-2000 includes a patented technology known as AcQviz that automatically and constantly measures and adjusts screen luminance to a fixed standard light level for vision testing.

The Company has also developedinvented a proprietary technology, embodied in the Company’s medical device, called the MapcatSF^®MapcatSF®, that accurately measures the macular pigment optical density (“MPOD”). The Company invented its own proprietary patented technology embodied in the MapcatSF. On November 8, 2016, the USPTOUnited States Patent and Trademark Office (“USPTO”) issued patent number 9,486,136 for the MapcatSF invention. Using the MapcatSF to measure the MPOD allows one to monitor the increase in the density of the macular protective pigment after taking the Lumega-Z medical food product.Lumega-Z. The MapcatSF is a non-mydriatic, non-invasive device that accurately measures the MPOD, the lens optical density and lens equivalent age, thereby creating an evidence-based protocol that is shared with the patient. A non-mydriatic device is one that does not require dilation of the pupil for it to function. The MapcatSF is intended to be the first medical device using a patented “single fixation” process and “automatic lens density correction” that produces accurate serialized data.

For the past three years, the clinical prototypes of the MapcatSF have been tested on patients, allowing for frequent modifications of the device’s algorithms and retesting for accuracy, as well as to provide the inclusion of additional features not previously found in the initial prototype. The alpha prototype, which is the pre-commercial production version, was unveiled for the first time in July 2013 in Cambridge, United Kingdom, to researchers and scientists from around the world. The MapcatSF is manufactured and assembled in Irvine, California, and will be distributed from the Company’s national headquarters in San Diego. The marketing of the device will be implemented through continuing education presentations conducted by key opinion leaders in the industry. The MapcatSF device is a Class I medical device under the U.S. Food and Drug Administration (“FDA”) classification scheme for medical devices, which the Company has determined does not require pre-market approval.

Lumega-Z is a medical food product that has a patent-pending formula that replenishesis designed to replenish and restoresrestore the macular protective pigment simultaneously delivering critical and essential nutrients to the eye. Management believes, based on review of products on the market and knowledge of the industry, that Lumega-Z is the first liquid ocular health formula to be classified as a medical food (as defined in Section 5(b) of the “Orphan Drug Act”). However, the FDA has not monitored nor approved Lumega-Z as a medical food. Formulated by Dr. Sheldon Hendler in 2010, modifications were made over a two-year period to improve the taste and method of delivery. We believeThe current formulation has been delivered to patients and used in clinics since 2014.

Medical foods are not considered to be either dietary or nutritional supplements. The Company believes that there is an increasing level of acceptance of medical foods as a primary therapy by patients and healthcare providers to treat pain syndromes, sleep and cognitive disorders, obesity, hypertension, and viral infection. In clinical practice, medical foods are being prescribed as both a standalone therapy and as an adjunct therapy to low doses of commonly prescribed drugs. We believeThe Company believes that medical foods will continue to grow in importance over the coming years.

By combining its MapcatSF medical device and Lumega-Z medical food, the Company has developed what it believes to be the only reliable two-pronged, evidence-based protocol for replenishing and restoring the macular protective pigment and increasing overall retinal health.

Recent Developments

VectorVision

On September 29, 2017, the Company, through a wholly-owned subsidiary, completed the acquisition of substantially all of the assets and liabilities of VectorVision, Inc., an Ohio corporation (“VectorVision Ohio”), in exchange for 3,050,000 shares of the Company’s common stock, pursuant to the terms of an Asset Purchase and Reorganization Agreement, dated September 29, 2017 (the “Asset Purchase Agreement”), which was entered into on an arm’s-length basis. The wholly-owned subsidiary that acquired the business is VectorVision Ocular Health, Inc., a Delaware corporation (“VectorVision”), doing business as VectorVision. VectorVision specializes in the standardization of contrast sensitivity, glare sensitivity, low contrast acuity, and ETDRS (“Early Treatment Diabetic Retinopathy Study”) visual acuity testing. VectorVision’s standardization system is designed to provide the practitioner or researcher with the ability to delineate very small changes in visual capability, either as compared to the population or from visit to visit.

VectorVision develops, manufactures and sells equipment and supplies for standardized vision testing for use by eye doctors in clinical trials, for real-world vision evaluation, and industrial vision testing. The Company believes VectorVision’s CSV-1000 device to be the standard of care for clinical trials. The acquisition of VectorVision expands the Company’s technical portfolio and the Company believes it further establishes the Company’s position at the forefront of early detection, intervention and monitoring of a range of eye diseases.

November Financing

On November 3, 2017 (the “Effective Date”), the Company completed the issuance and sale of an aggregate of 4,347,827 shares of common stock (the “Shares”) at a purchase price of $1.15 per Share (or a purchase price of $5,000,001.05 in the aggregate), in a private placement (the “Private Placement”) to certain purchasers (the “Purchasers”) pursuant to a Stock Purchase Agreement dated as of November 3, 2017 (the “Purchase Agreement”), by and among the Company and the Purchasers.

The Purchasers consist of Lianluo Smart Limited, a company listed on the NasdaqCM (trading symbol: LLIT) and based in Beijing, China (“LLIT”), and its affiliated company, Digital Grid (Hong Kong) Technology Co., Limited (“Digital Grid”). Pursuant to the Purchase Agreement, LLIT purchased 1,304,348 Shares for a total investment of $1,500,000.20 and Digital Grid purchased 3,043,479 Shares for a total investment of $3,500,000.85. Hangzhou Lianluo Interactive Information Technology Co., Ltd., a company listed on the Shenzhen Stock Exchange (trading symbol: 002280), owns 64.18% of LLIT and 100% of Digital Grid.

Until the one year anniversary of the Effective Date, or earlier in the event that the Purchasers (including their affiliates) hold less than three percent (3%) of the issued and outstanding shares of common stock of the Company, the Company may not undertake a reverse stock split or equivalent reclassification of the Company’s shares of common stock without the prior written consent of the Purchasers holding a majority of the Shares issued pursuant to the Purchase Agreement which are then outstanding.

Pursuant to the Purchase Agreement, the Purchasers will have customary preemptive rights to participate in future equity and equity-linked issuances by the Company up to the extent necessary to maintain such Purchaser’s pro rata ownership percentage in the Company’s securities, subject to customary exceptions. The preemptive rights shall terminate at the earlier of (i) 18 months from the Effective Date, (ii) such time as the Purchasers hold less than five percent (5%) of the issued and outstanding shares of the Company’s common stock, or (iii) such time as the shares of common stock of the Company shall become listed or approved for listing on a national securities exchange.

The Shares issued pursuant to the Purchase Agreement were issued in reliance upon the exemption from registration pursuant to Section 4(a)(2) and Rule 903 of Regulation S promulgated under the Securities Act.

Conversion of Preferred Stock

The Company had previously issued and had outstanding shares of Series A Convertible Preferred Stock and Series B Convertible Preferred Stock (collectively, the “Preferred Stock”). The completion of the Private Placement triggered, at the Company’s election, the automatic conversion of the Preferred Stock into shares of common stock. Immediately following the completion of the Private Placement on November 3, 2017, the Company elected to effect the conversion of all outstanding shares of Preferred Stock into 6,981,938 shares of common stock (excluding accrued but unpaid dividends). The Company issued 205,242 shares of common stock for the accrued but unpaid dividends from October 1, 2017 through the Effective Date, representing the payment in full of all Preferred Stock dividend obligations.

Going Concern

The Company’s financial statements have been prepared assuming it will continue as a going concern. We have utilized cash in operating activities of $1,914,745 and $1,196,415 during the nine months ended September 30, 2017 and 2016, respectively, and had a total stockholders’ deficiency of $345,574 as of December 31, 2016. We expect to continue to incur net losses and negative operating cash flows in the near-term. The Company has completed multiple capital financing transactions during 2017, resulting in cash on hand of $1,269,755 at September 30, 2017, and an additional $5,000,000 was received on November 3, 2017.

As of December 31, 2016, management had concluded that there was substantial doubt about the Company’s ability to continue as a going concern within one year of the date that the financial statements were issued, and the Company’s independent registered public accounting firm also included explanatory going concern language in their report accompanying the Company’s audited financial statements for the year ended December 31, 2016. The Company’s financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from the possible inability of the Company to continue as a going concern.

The Company will continue to incur significant expenses for commercialization activities related to its lead products Lumega-Z, the MapcatSF medical device, and the CSV-1000 and ESV-3000 testing devices, and with respect to efforts to continue to build its infrastructure. Development and commercialization of medical foods and medical devices involves a lengthy and complex process. Additionally, the Company’s long-term viability and growth may depend upon the successful development and commercialization of products other than Lumega-Z, the MapcatSF or the CSV-1000 and ESV-3000 testing devices. The Company continues to attempt to raise additional debt and/or equity capital to fund future operations, but there can be no assurances that it will be able to secure such additional financing in the amounts necessary to fully fund its operating requirements on acceptable terms or at all. If the Company is unable to access sufficient capital resources on a timely basis, it may be forced to reduce or discontinue its technology and product development programs and curtail or cease operations. Any such event would have a material adverse effect on the Company’s financial results and the market value of its common stock.

Corporate Strategy

Since there are no research-validated pharmaceutical offerings for slowing the progression of adult macular degeneration (“AMD”), it is necessary for physicians to recommend Age-Related Eye Disease Study (“AREDS”)-based supplements to their AMD patients. However, more than 90% of all AREDS-based nutritional products currently on the market are in tablet, capsule and gel capsule form. Tablets, capsules and gel capsules are difficult to administer and have a low efficiency of absorption. For this reason, some doctors may hesitate to prescribe tablet, capsule or gel capsule AREDS-based nutraceuticals despite the fact that these currently may be the only option available to them.

The competitive landscape of supplements is crowded and confusing for physicians and patients looking to obtain an appropriate product for eye care. In October 2017, while searching walgreens.com for “AREDS” we found 10 results, all of which are in tablet, capsule or gel capsule form. When searching the same website for “Eye Health Supplements” (a common search term for this category of product) we found 204 products, of which 196 (96%) are in tablet, capsule or gel capsule form. The same search term on cvs.com returned over 110 products. These supplement products all have varying ingredients, varying levels of similar ingredients, varying claims regarding their effects, and varying price points.

Lumega-Z is designed to address this concern. In contrast, Lumega-Z is a liquid formulated using a proprietary molecular micronization process (“MMP”) designed to maximize efficiency of absorption and safety and to minimize compatibility issues. The MMP is a proprietary homogenization process whereby the molecular structure of the ingredients is reduced in size to facilitate more efficient absorption in the body.

Medical Foods Products Industry Overview

The Company believes that the science of nutrition was long overlooked and underdeveloped. The Company believes that the sick and elderly have special nutritional needs that cannot be met by traditional adult diets. Medical nutrition has emerged as a large and attractive segment in the food industry today.

A number of diseases are associated with metabolic imbalances. Patients in treatment for certain diseases have specific nutritional requirements. Some examples are ocular health, pain syndromes, insomnia, cognitive disorders, IBS, and heart disease. Many older Americans have or will develop chronic diseases that are amenable to the dietary management benefits of medical foods. Medical foods help address these diseases and conditions in a drug-free way with food-based ingredients, yet are a medical product taken under the supervision of a physician. The term “medical foods” does not pertain to all foods fed to sick patients. Medical foods are foods that are specially formulated and processed (as opposed to a naturally occurring foodstuff used in a natural state) for patients who are seriously ill or who requires the product as a major treatment modality according to FDA regulations.

Medical foods consist of food-based ingredients that are part of the normal human diet and are Generally Recognized as Safe (“GRAS”) under FDA standards. To be classified as aregulated medical food the foods must make disease claims for which there is scientific evidence for the nutrient deficiencies that cannot be corrected by normal diet. Medical foods are intended for a vulnerable population suffering from a particular chronic disease and so have special, extra-rigorous guarantees of safety. All ingredientstherefore must be designated GRAS and used in therapeutic concentrations to address the particular nutritional needs of the patient. Medical foods are takenadministered under the supervision of a physician or professional healthcare provider who monitorsprovider. In order to reach the large, expanding AMD patient population, the Company primarily markets Lumega-Z to patients through ophthalmologists and adjusts the food ‘dosage.’ In addition, under FDA guidelines and congressionally approved laws, medical foods do not require FDA preapproval but undergo continuous FDA monitoring and approval of label claims. Even though pre-market FDA approval is not required for a medical food, the official requirements and responsibilities for the manufacturer, in terms of safety, are greater than for dietary supplements, including the requirements for solid scientific support for the formula as a whole. For these reasons, we believe that medical foods have greater guarantees of efficacy. In contradistinction, dietary supplements, such as vitamins, minerals and botanicals, do not require FDA preapproval, cannot make disease claims, are intended for average people without disease, and cannot legally claim that they prevent, mitigate or treat a given disease. Dietary supplements do not require physician supervision and can be administered to a person that can self-administer the supplement without supervision.optometrists.

Prior to 2015,Over 1,900 patients have been treated with Lumega-Z was categorizedsince the Company began selling the formulation in October 2011. The patients come from a combination of the three initial testing sites, healthcare provider sites where the MapcatSF has been demonstrated, patients that have found Lumega-Z online and sold as a dietary supplement. We believe that Lumega-Z is properly categorized as a medical food. While it is unlikely the FDA would conclude otherwise, if the FDA were to determine Lumega-Z should not be defined as a medical food, we would need to relabel and rebrand that product. We believe there would be a non-material impact on the Company’s operations and financial condition if we were required to change labeling and packaging back to that of a dietary supplement. While reclassification and the subsequent relabeling and rebranding would be an added cost to operations, we do not believe it would change the use or effectiveness of Lumega-Z. Although, we believe it is unlikely the FDA would make such a determination that Lumenga-Z is not a medical food, there is a chance that certain physicians may choose not to recommendthrough other patient referrals, healthcare provider sites administering Lumega-Z to their patients without use of the MapcatSF, and MapcatSF devices recently placed in additional healthcare facilities. Patients take Lumega-Z under the supervision of their physician. Lumega-Z is typically ingested by the patient on a daily basis. Patients are typically between 50 and 80 years old. Patients are mixed ethnically and socioeconomically. Patients typically have insurance, whether private insurance or Medicare. Physicians have determined that certain consumers may choose not to buy Lumega-Z if itthe patient is not classified asexperiencing or is at a high risk of developing retinal disease and decide based on their medical food.determination that the patient is a candidate for Lumega-Z.

Vision Testing Industry OverviewNearly half of Americans have low MPOD, a risk factor for AMD. As the MapcatSF is specifically designed to measure the MPOD, the Company and the physicians that utilize the MapcatSF are able to observe changes in that macular protective pigment density in patients who are taking Lumega-Z. The Company encourages sites using the MapcatSF® to provide the Company anonymized data on the MPOD readings. Anecdotal reports from physicians indicate improvements in their patients such as increased visual function, a noticeable halt in the progression of the patient’s AMD, improvement in glare and contrast sensitivity, and stabilization and improvement of vision. No adverse effects of taking Lumega-Z have been reported by any of the physicians administering Lumega-Z to their patients.

We believeThe number of patients regularly ordering Lumega-Z has increased as new healthcare providers have begun working with the Company, with a concurrent rise in patients set on an auto-ship program for delivery every four weeks. Automatic shipment has an added benefit in that repeatable, consistent resultsit aids physicians because it increases patient compliance in using Lumega-Z on a regular basis. The Company’s operations, to date, indicate that each MapcatSF deployed in a clinic can generate an average of 75 new customers for visual acuity testingits Lumega-Z product over a period of approximately 90 days when a MapcatSF is deployed in a small, low volume clinic. A larger, higher volume clinic is expected to generate a larger number of paramount importance for effective eye health care and for accurately establishing and enforcingpatients in a shorter period of time. All of the vision performance criteria for certain professions. Variance in test lightingCompany’s medical food revenue is derived from a majorlimited number of individual customers.

AMD is the third leading cause of inconsistencyblindness in vision testing results. Standards for testing luminance, have been in place for morethe world. More than three decades. However, recently, vision testing has evolved from the use of projection systems and charts to the use of digital displays. We believe that the variance in luminance provided by digital displays is large, and clinicians are now obtaining highly inconsistent results from practice to practice. We believe more than 250,000 eye care examination rooms are in use10 million people in the United States today.suffer from various forms of this incurable disease, according to the American Macular Degeneration Foundation. As the population ages, that number is expected to triple by 2025. Congress, the Food and Drug Administration, the Center for Medicare & Medicaid Services and private insurance companies are focusing increased efforts on pharmacovigilance (the branch of the pharmaceutical industry which assesses and monitors the safety of drugs either in the development pipeline or which have already been approved for marketing) to measure and reduce these adverse health consequences.

The Company believes that there is an increasing level of acceptance of medical foods as a primary therapy by patients and healthcare providers to treat pain syndromes, sleep and cognitive disorders, obesity, hypertension, and viral infection. In clinical practice, medical foods are being prescribed as both a standalone therapy and as an adjunct therapy to low doses of commonly prescribed drugs. From a regulatory standpoint, the FDA took steps in 1988 to encourage the development of medical foods by regulating this product category under the Orphan Drug Act. The term “medical food” as defined in Section 5(b) of the Orphan Drug Act is a “food which is formulated to be consumed or administered internally (by mouth) under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” This definition was incorporated by reference into the Nutrition Labeling and Education Act of 1990.

These regulatory changes have reduced the costs and time associated with bringing medical foods to market. Until 1972, medical foods were categorized as drugs and then until 1988 as “foods for special dietary purposes.” The field of candidates for development into medical foods is expanding due to continuing advances in the understanding of the science of nutrition and disease, coupled with advances in food technology thereby increasing the number of products that can be formulated and commercialized.

In addition to its medical food products, the Company, through its wholly owned subsidiary NutriGuard Formulations, Inc., recently acquired NutriGuard Research, Inc. See “Recent Developments” below. Pursuant to the Asset Purchase Agreement, the Company agreed to purchase specified assets of the NutriGuard brand and business, primarily consisting of inventory, trademarks, copyrights and other intellectual property. Once developed, the NutriGuard Formulations nutraceutical product line should provide the Company a new direct-to-consumer (“DTC”) capability. The Company intends to build a portfolio of nutraceutical products under the NutriGuard brand by developing new formulations and marketing its products to patients directly through DTC channels and through recommendations by their physicians.

The Company distributes its medical food products through E-commerce in an online store that is operated atwww.guardionhealth.com. Information about VectorVision products can be found at www.vectorvision.com.

Recent Developments

Operating Results

We are in the process of preparing our results for our fiscal quarter ended September 30, 2019. Based on currently available information, we estimate that, for the third fiscal quarter, total revenue will be in the range of approximately $150,000 to $160,000.

The decrease in total revenue as compared to approximately $261,000 in the second quarter of 2019 and $294,000 in the third quarter of 2018 can be attributed primarily to a reduction in sales of the Vector Vision CSV-1000 product in the third quarter of 2019 as compared to the prior periods, which we believe resulted from the Company’s announcement in the third quarter of 2019 that it is releasing the new CSV-2000 product. Although the CSV-1000 will continue to be sold, the Company plans to put a greater focus on sales and marketing efforts of the new CSV-2000 beginning in the fourth quarter of 2019.

This unaudited preliminary financial information for the fiscal quarter ended September 30, 2019 is based upon our estimates and subject to completion of our quarter end financial results. Moreover, this data has been prepared solely on the basis of currently available information by, and is the responsibility of, management. The unaudited preliminary financial information for the fiscal quarter ended September 30, 2019 has not been reviewed or audited by our independent public accounting firm in accordance with PCAOB standards. This preliminary financial information is not a comprehensive statement of our financial results for this period, and our actual results may differ materially from these estimates due to the completion of our financial closing procedures, final adjustments, and other developments that may arise between now and the time the closing procedures for the fiscal quarter are completed. Therefore, you should not place undue reliance upon these preliminary financial results. There can be no assurance that these estimates will be realized, and estimates are subject to risks and uncertainties, many of which are not within our control. See “Cautionary Note Regarding Forward-Looking Statements.”

Initial Public Offering

On April 9, 2019, the Company closed its initial public offering (the “IPO”) of 1,250,000 shares of common stock, par value $0.001 per share, at an IPO price to the public of $4.00 per share resulting in net proceeds to the Company of $3,888,000 after all costs and expenses. The shares began trading on the NASDAQ Capital Market on April 5, 2019 under the symbol “GHSI.”

VectorVision is

Follow-On Public Offering

On August 15, 2019, the only companyCompany consummated an underwritten public offering (the “August Offering”) of (i) 12,000,000 shares of common stock, (ii) pre-funded warrants exercisable for 1,000,000 shares of common stock (the “August Pre-Funded Warrants”), and (iii) warrants to purchase up to an aggregate of 13,000,000 shares of common stock (the “August Warrants”). The August Offering was conducted pursuant to an Underwriting Agreement, dated August 13, 2019 by and between the Company and Maxim Group LLC and WallachBeth Capital, LLC. On August 16, 2019, the Company sold an additional 1,950,000 August Warrants upon exercise of the underwriters’ over-allotment option. The net proceeds to the Company from the August Offering, after deducting underwriting discounts and commissions and other estimated expenses was approximately $4.9 million.

The public offering price was $0.44 per share of common stock and $0.01 per accompanying August Warrant. Each August Warrant represents the right to purchase one share of common stock at an exercise price of $0.585 per share. The August Warrants are exercisable immediately, expire five years from the date of issuance and provide that, offers fully standardized vision testing products that are designed to ensure consistent, repeatablebeginning on the earlier of (i) September 11, 2019 and highly accurate results. The CSV-1000 and ESV-3000 devices offer auto-calibrated tests designed to ensure(ii) the correct testing luminance and contrast levels for consistent, highly accurate and repeatable results,date on which is why the VectorVision instruments can detect and quantify subtle changes in vision, and why the VectorVision CSV-1000 instrument is used worldwide by eye doctors incommon stock traded an aggregate of more than 60 countries to accomplish contrast sensitivity testing. For40,000,000 shares after the same reasons,announcement of the Company believes thatpricing of the ESV-3000 ETDRS testing device will becomeAugust Offering, and ending on the worldwide standardtwelve (12) month anniversary thereof, each August Warrant may be exercised at the option of the holder on a cashless basis at a ratio of one August Warrant for ETDRS visual acuity testing. The Company’s research has revealed no competing products that offers auto-calibrationone share of ambient illumination. Competitive devices do not allow for variationscommon stock, in ambient light levels, resultingwhole or in variabilitypart, if the weighted average price of test results duethe Common Stock on the trading day immediately prior to the environment in whichexercise date fails to exceed the testing is performed. The CSV-1000 and ESV-3000 use self-calibrated test lighting. The self-calibrated test lighting is proprietary, and the test facesinitial exercise price of the CSV-1000 are proprietaryAugust Warrant. As of October 24, 2019, 1,000,000 August Pre-Funded Warrants have been exercised for proceeds of $10,000 and the intellectual property is protected under copyright and trade secret law. Both CSV-1000 and ESV-3000 are currently sold in multiple countries,14,723,800 August Warrants have been exercised on a cashless basis, and the Company expects this global distributionhas issued an aggregate of 15,723,800 shares of common stock upon such exercises.

NutriGuard Acquisition

Effective September 20, 2019 (the “Effective Date”), the Company’s newly-formed wholly-owned subsidiary, NutriGuard Formulations, Inc., a Delaware corporation (“Buyer”), entered into an asset purchase agreement (the “Asset Purchase Agreement”) with NutriGuard Research, Inc., a California corporation (“NutriGuard”), and NutriGuard’s sole shareholder, Mark McCarty (the “NutriGuard Acquisition”). The NutriGuard Acquisition closed on the Effective Date.

Pursuant to continue. There isthe Asset Purchase Agreement, Buyer agreed to purchase from NutriGuard specified assets of the NutriGuard brand and business, primarily consisting of inventory, trademarks, copyrights and other intellectual property. In exchange, Buyer agreed to pay a training requirement in incorporatingroyalty fee to NutriGuard subsequent to meeting certain financial performance metrics based on the CSV-1000 deviceoperating results of the NutriGuard brand of products following the Effective Date. NutriGuard and Mr. McCarty also agreed, among other terms, to no longer use the “NutriGuard” name upon the Effective Date.

Pursuant to the terms of the Asset Purchase Agreement, Mr. McCarty entered into clinical practice,a consulting agreement (the “Consulting Agreement”) with Buyer pursuant to which Mr. McCarty will provide consulting services to, and serve as the Director of Research of, Buyer. Additionally, the Company plansagreed to grant to Mr. McCarty stock options to purchase 100,000 shares of the Company’s common stock, exercisable at a price of $0.5411 per share (which was the closing price of the Company’s common stock on the Effective Date). The options were granted under the terms of the Company’s 2018 Equity Incentive Plan, which options vest as follows: 25% on the Effective Date, 25% on the first anniversary following the Effective Date, 25% on the second anniversary following the Effective Date, and 25% on the third anniversary following the Effective Date. The vested portion of the options may be exercised at any time prior to the earliest to occur of: (a) the 5^th anniversary of the Effective Date; (b) 90 days following the termination of the Consulting Agreement for any reason other than “for cause”; (c) 6 months following termination of the Consulting Agreement due to Mr. McCarty’s death or disability; or (iv) in the event of a termination of Mr. McCarty “for cause” under the Consulting Agreement.

NASDAQ Notice

On September 20, 2019, the Company received a notification letter from the Nasdaq Listing Qualifications Staff (the “Staff”) of the Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that, for the last 30 consecutive business days, the closing bid price for the Company’s common stock was below the minimum $1.00 per share requirement for continued listing on The Nasdaq Capital Market as set forth in Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”). The Nasdaq letter has no immediate effect on the listing of the Company’s common stock on the Nasdaq Capital Market.

In accordance with Nasdaq listing rules, the Company has been provided an initial period of 180 calendar days, or until March 18, 2020 (the “Compliance Date”), to regain compliance with the Minimum Bid Price Requirement. If, at any time during this 180-day period, the closing bid price of the Company’s common stock is at least $1.00 for a minimum of 10 consecutive business days, the Staff will provide the Company written confirmation of compliance with the Minimum Bid Price Requirement and the matter will be closed. If the Company does not regain compliance by the Compliance Date, the Company may be eligible for an additional 180 calendar day compliance period. To qualify for such additional compliance period, the Company would have to meet the continued listing requirements of the NASDAQ Capital Market, except for the Minimum Bid Price Requirement, and the Company would need to provide as partwritten notice of its commercialization strategy.intention to cure the deficiency during the additional compliance period. If the Company is not eligible for the additional compliance period or it appears to the Staff that the Company will not be able to cure the deficiency or if the Staff exercises its discretion to not provide such additional compliance period, the Staff will provide written notice to the Company that its common stock will be subject to delisting. At that time, the Company may appeal the Staff’s delisting determination to a Nasdaq Hearing Panel.

Risk Factors Summary

An investment in the Company’s common shares involves a high degree of risk. You should carefully consider the risks summarized below. The risks are discussed more fully in the “Risk Factors” section of this prospectus immediately following this prospectus summary. These risks include, but are not limited to, the following:

Implications of Being an Emerging Growth Company

We areThe Company is an emerging growth company as defined in the Jumpstart Our Business Startups Act of 2012, as amended or the JOBS Act. We(the “JOBS Act”). It will remain an emerging growth company until the earlier of (1) the last day of the fiscal year following the fifth anniversary of the completion of thisour initial public offering, (2) the last day of the fiscal year in which we haveit has total annual gross revenue of at least $1.07 billion, as such amount is indexed for inflation every five years by theSecurities and Exchange Commission to reflect the change in the Consumer Price Index for All Urban Consumers during its most recently completed fiscal year, (3) the last day of the fiscal year in which we arethe Company is deemed to be a “large accelerated filer” as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended or the Exchange Act,(the “Exchange Act”), which would occur if the market value of ourthe Company’s common stock held by non-affiliates exceeded $700.0$700 million as of the last business day of the second fiscal quarter of such fiscal year, or (4) the date on which we havethe Company has issued more than $1.0$1 billion in non-convertible debt securities during the prior three-year period. An emerging growth company may take advantage of specified reduced reporting requirements and is relieved of certain other significant requirements that are otherwise generally applicable to public companies. As an emerging growth company:

In addition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This provision allows an emerging growth company to delay the adoption of some accounting standards until those standards would otherwise apply to private companies. We haveThe Company has elected to take advantage of the benefits of this extended transition period. OurIts financial statements may therefore not be comparable to those of companies that comply with such new or revised accounting standards.

Corporate History and Information

Guardion Health Sciences, Inc. was formed under the name P4L Health Sciences, LLC in December, 2009 in California as a limited liability company. The Company changed its name to Guardion Health Sciences, LLC (“GHS”) in December 2009. In June 2015, GHS becameconverted into a Delaware “C” corporation. The Company’s address is 15150 Avenue of Science, Suite 200, San Diego, California 92128. OurThe Company’s telephone number is 858-605-9055. OurIts website is: www.guardionhealth.com. The information on, or that can be accessed through, ourthis website is not part of this prospectus, and you should not rely on any such information in making the decision whether to purchase ourthe Company’s common stock.

THE OFFERING

(1) The number of shares of common stock outstanding is based on 40,545,94750,482,562 shares of common stock issued and outstanding as of NovemberOctober 24, 20172019 and excludes the following: options to purchase 1,375,000 shares of common stock and warrants to purchase 2,983,666 shares of common stock.

Summary Financial Information

The following summary financial and operating data set forth below should be read in conjunction with our financial statements, the notes thereto and the other information contained in this prospectus. The summary statement of operations data for the years ended December 31, 2016 and 2015 have been derived from our audited financial statements appearing elsewhere in this prospectus. The summary balance sheet data as of September 30, 2017, and the statement of operations data for the nine months ended September 30, 2017 and 2016, have been derived from our unaudited condensed consolidated financial statements appearing elsewhere in this prospectus. The unaudited financial statements were prepared on a basis consistent with our audited financial statements and include, in the opinion of management, all adjustments necessary for the fair presentation of the financial information contained in those statements. The historical results presented below are not necessarily indicative of financial results to be achieved in future periods.

Statement of Operations Data:

Balance Sheet Data:

INCORPORATION OF CERTAIN INFORMATION BY REFERENCE

The SEC allows the Company to “incorporate by reference” the information it has filed with the SEC, which means that the Company can disclose important information to you by referring you to those documents. The information that the Company incorporates by reference is an important part of this prospectus, and information that it files later with the SEC will automatically update and supersede this information. The documents the Company is incorporating by reference are:

All documents the Company subsequently files with the SEC pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act, except as to any portion of any report or documents that is not deemed filed under such provisions, (1) on or after the date of filing of the registration statement containing this prospectus and prior to the effectiveness of the registration statement and (2) on or after the date of this prospectus until the earlier of the date on which all of the securities registered hereunder have been sold or the registration statement of which this prospectus is a part has been withdrawn, shall be deemed incorporated by reference in this prospectus and to be a part of this prospectus from the date of filing of those documents and will be automatically updated and, to the extent described above, supersede information contained or incorporated by reference in this prospectus and previously filed documents that are incorporated by reference in this prospectus.

Nothing in this prospectus shall be deemed to incorporate information furnished but not filed with the SEC pursuant to Item 2.02, 7.01 or 9.01 of Form 8-K.

Upon written or oral request, we will provide without charge to each person to whom a copy of the prospectus is delivered a copy of the documents incorporated by reference herein (other than exhibits to such documents, unless such exhibits are specifically incorporated by reference herein). You may request a copy of these filings, at no cost, by writing or telephoning us at the following address: Vincent J. Roth, the Company’s General Counsel, at Guardion Health Sciences, Inc., 15150 Avenue of Science, Suite 200, San Diego, CA 92128; Tel: 858-605-9055. We maintain a website at https://guardionhealth.com/sec-filings/. You may access our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and other reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act with the SEC free of charge at our website as soon as reasonably practicable after such material is electronically filed with, or furnished to, the SEC. The information contained in, or that can be accessed through, our website is not incorporated by reference in, and is not part of, this prospectus.

RISK FACTORS

Investing in the Company’s common stocksecurities involves a high degree of risk. Prospective investors should carefully consider the risks described below, together with all of the other information included or referred to in this prospectus, before purchasing shares of the Company’s common stock.Company securities. There are numerous and varied risks that may prevent the Company from achieving its goals. If any of these risks actually occurs, ourthe Company’s business, financial condition or results of operations may be materially adversely affected. In such case, the trading price of ourits common stock could decline and investors in ourthe Company’s common stock could lose all or part of their investment.

Risks Related to the Company’s Business

The Company’s recurring operating losses have raised substantial doubt regarding its ability to continue as a going concern.

TheAs the Company has sustainedincurred recurring operating losses which raises substantial doubt about its ability to continue as a going concern. The perception ofand negative cash flows since our inception, there is no assurance that the Company’s abilityCompany will be able to continue as a going concern absent additional financing, which the Company may make it more difficult for itnot be able to obtain financing for the continuation of its operationson favorable terms or at all.

The Company has incurred net losses since inception in 2009 and could result in the loss of confidence by investors, suppliers and employees. The Company’s financial statements for all periods have been prepared assumingcannot be certain if or when the Company will continue as a going concern. As discussed in Note 1produce sufficient revenue from operations to the Financial Statements, the continuation of the Company as a going concern is dependent upon the Company raising additional debt and/or equity financing to fund future operations and to provide additional working capital.support costs. The Company has completed multiple capital financing transactions during 2017, resulting in cash on handhad a net loss of $1,269,755 at September 30, 2017, and an additional $5,000,000 was received on November 3, 2017 in connection with the private placement transaction referred to elsewhere in this prospectus.

As of December 31, 2016, management had concluded that there was substantial doubt about the Company’s ability to continue as a going concern within one year of the date that the financial statements were issued, and the Company’s independent registered public accounting firm also included explanatory going concern language in their report accompanying the Company’s audited financial statements$7,767,407 for the year ended December 31, 2016.2018 and a net loss of $5,305,169 for the year ended December 31, 2017. The Company had a net loss of $4,437,177 for the six months ended June 30, 2019. The Company had an accumulated deficit of $39,070,540 as of June 30, 2019. The Company expects to continue to incur net losses and negative operating cash flows in the near-term.

Although recent capital transactions have significantly improved our current cash position, we

The Company will continue to incur significant expenses for commercialization activities related to ourits lead product Lumega-Z, the MapcatSF medical device, the CSV-1000, CSV-2000 and ESV-3000 devices, the new NutriGuard nutraceuticals product line, and with respect to efforts to build its infrastructure and expand its operations.

Even if profitability is achieved in the future, the Company may not be able to sustain profitability on a consistent basis. The Company expects to continue to incur substantial losses and negative cash flow from operations for the foreseeable future. The Company’s financial statements included in this registration statement have been prepared assuming that the Company will continue as a going concern. The Company’s auditors have made reference to the substantial doubt as to our infrastructure.ability to continue as a going concern in their audit report on its audited financial statements for the year ended December 31, 2018. Because the Company has been issued an opinion by its auditors that substantial doubt exists as to whether the Company can continue as a going concern, it may be more difficult for the Company to attract investors. The Company’s future is dependent upon its ability to obtain financing and upon future profitable operations.

The Company does not have any credit facilities as a source of present or future funds, and there can be no assurance that the Company will be able to raise sufficient additional capital on acceptable terms, or at all. The Company may seek additional capital through a combination of private and public equity offerings and debt financings, including through this offering. If the Company raises additional funds through the issuance of equity or convertible debt securities, the percentage ownership of our stockholders could be significantly diluted, and these newly issued securities may have rights, preferences or privileges senior to those of existing stockholders. Debt financing, if obtained, may involve agreements that include covenants limiting or restricting the ability to take specific actions, such as incurring additional debt, would increase expenses and require that Company assets secure such debt. Moreover, any debt the Company incurs must be repaid regardless of our operating results.

The Company’s ability to obtain additional financing in the future will be subject to a number of factors, including market conditions, operating performance and investor sentiment. If the Company is unable to raise additional capital when required or on acceptable terms, the Company will be forcedmay have to suspendsignificantly delay, scale back or terminatediscontinue our operations and, in all likelihood, cause investors to lose their entire investment.

The Company has significant working capital requirements and has historically experienced negative working capital balances. If the Company continues to experience such negative working capital balances in the future, it couldor obtain funds by entering into agreements on unattractive terms, which would likely have a material adverse effect on its business, financial conditionstock price and results of operations.

As a result of its continued losses, the Company’s current liabilities often significantly exceed current assets.  The Companyrelationships with third parties, at least until additional funding is dependent upon obtaining additional financing to meet working capital needs and repay outstanding debt. Since its formation,obtained. If the Company has relied on convertible notes and direct stock purchases from unrelated partiesdoes not have sufficient funds to fund its operating cash flow deficits. There is no assurancecontinue operations, the Company could be required to seek other alternatives that it will generate the necessary net incomewould likely result in our stockholders losing some or operating cash flows to meet its working capital requirements and pay its debts as they become due in the future due to a varietyall of factors and other factors discussed in this “Risk Factors” section. There can be no assurance, however, that it will be able to successfully take any of these actions, including adjusting expenses sufficiently or in a timely manner, or raising additional equity, increasing borrowings or completing a financing on any terms or on terms that are acceptable to it. The Company’s inability to take these actions as and when necessary would materially adversely affect its liquidity, results of operations, financial condition and ability to operate.their investment.

The Company’s future success is largely dependent on the successful commercialization of Lumega-Z^® and, GlaucoCetin, the MapcatSF^®MapcatSF® medical device, and the VectorVision CSV-1000 and ESV-3000 testing devices, and the successful integration of VectorVision into the Company’snewly acquired NutriGuard nutraceuticals business.

The future success of the Company’s business is largely dependent upon the successful commercialization of its medical food,foods, Lumega-Z and GlaucoCetin, its medical device, the MapcatSF, and the VectorVision CSV-1000, CSV-2000 and ESV-3000 testing devices.devices and its newly acquired NutriGuard nutraceuticals business. The Company is dedicating a substantial amount of its resources to advance the Lumega-Z and certainGlaucoCetin medical foods, the MapcatSF, CSV-1000 and ESV-3000 medical devices and is now starting to direct resources to advance MapcatSF as aggressively as possible.at developing the NutriGuard product line and the launch of the CSV-2000. If the Company encounters difficulties in the commercialization of Lumega-Z its medical foods, medical devices and/or the MapcatSF,nutraceuticals, the Company will not have the resources necessary to continue its business in its current form. If the Company is unable to establish and maintain adequate sales, marketing and distribution capabilities or enter into or maintain agreements with third parties to do so, it may be unable to successfully commercialize its products. The Company believes it is creating an efficient commercial organization and taking advantage of outsourcing options where prudent to maximize the effectiveness of its commercial expenditures. However, it may not be able to correctly judge the size and experience of the sales and marketing force and the scale of distribution necessary to be successful. Establishing and maintaining sales, marketing, and distribution capabilities are expensive and time-consuming. Such expenses may be disproportionate compared to the revenues the Company may be able to generate on sales of Lumega-Z, GlaucoCetin or the NutriGuard products or licensing fees or sales of the MapcatSF device or the CSV-1000, CSV-2000 and ESV-3000 testing devices. If this occurs, it will have an adverse impact on operations and the Company’s ability to fund any future development.

WeThe Company may fail to realize all of the anticipated benefits of the VectorVision acquisitionacquistion and NutriGuard Acquisition or those benefits may take longer to realize than expected. WeThe Company may also encounter significant difficulties in integrating VectorVision and NutriGuard into the existing business and VectorVision and NutriGuard may underperform relative to ourthe Company’s expectations.

Our abilityThe Company may not fully realize the anticipated benefits of the VectorVision acquisition and NutriGuard Acquisition. The Company has integrated the business of VectorVision and begun to integrate NutriGuard with its legacy businesses, and the Company may continue to devote significant management attention and resources to operate and grow these businesses. The failure to realize the anticipated benefits of the VectorVision acquisition will depend, to a large extent, on our ability to integrateand the business of VectorVision with our legacy business, which may be a complex, costly and time-consuming process. We may be required to devote significant management attention and resources to integrate the VectorVision business practices into our existing operations. The integration process may disrupt our business and, if implemented ineffectively, could restrict the realization of the full expected benefits of the acquisition. The failure to meet the challenges involved in the integration process and to realize the anticipated benefits of the VectorVision acquisitionNutriGuard Acquisition could cause an interruption of, or a loss of momentum in, ourthe Company’s operations and could adversely affect ourits business, financial condition and results of operations.

In addition, the integrationcontinued operation of VectorVision and NutriGuard may result in material unanticipated problems, expenses, liabilities, competitive responses, loss of customers and other business relationships, and diversion of management’s attention. Additional integration challenges may include, among other things:

Many of these factors will be outside of our control and any one of them could result in increased costs, decreases in the amount of expected revenues and diversion of management’s time and energy, which could adversely affect our business, financial condition and results of operations. In addition, even if VectorVision is integrated successfully, the full anticipated benefits of such acquisition may not be realized, including the synergies, cost savings or sales or growth opportunities that are anticipated. These benefits may not be achieved within the anticipated time frame, or at all. Additionally, we may not be able to maintain the growth rate, levels of revenue, earnings or operating efficiency that we or VectorVision have achieved prior to the acquisition or might have achieved separately.NutriGuard.

We haveThe Company has limited experience in developing medical foods, and medical devices and wenutraceuticals and it may be unable to commercialize some of the products we develop.and services it develops or acquires.

Development and commercialization of medical foods and medical devices involves a lengthy and complex process. We haveThe Company has limited experience in developing products and havehas only onetwo commercialized medical food productproducts on the market, Lumega-Z.Lumega-Z and GlaucoCetin. In addition, no one has ever developed or commercialized a medical device like the MapcatSF, and weMapcatSF. The Company cannot assure you that it is possible to further develop or successfully commercialize the MapcatSF or that weit will be successful in doing so. While the CSV-1000 and ESV-3000 visual acuity testing devices are commercialized, there is no guarantee that they will continue to be marketable or enjoy commercial success. The Company is preparing to launch the CSV-2000, but there is no assurance the introduction of the instrument will be successful. Furthermore, there is no guarantee that the NutriGuard nutraceuticals will be marketable or that the Company will achieve commercial success with the product line.

Even if we developthe Company develops or acquires products for commercial use, these products may not be accepted by the medical and pharmaceutical marketplaces or be capable of being offered at prices that will enable usthe Company to become profitable. WeThe Company cannot assure you that ourits products will be approved by regulatory authorities, if required, or ultimately prove to be useful for commercial markets, meet applicable regulatory standards, or be successfully marketed.

We

The Company’s ongoing investment in new businesses and ournew products, services, and technologies is inherently risky, and could disrupt its current operations.

The Company has invested and expects to continue to invest in new businesses, products, services, and technologies. The expansion into the transcranial doppler testing businessis a reflection of its ongoing efforts to innovate and provide useful products and services. Such endeavors involve significant risks and uncertainties, including insufficient revenues from such investments to offset any new liabilities assumed and expenses associated with these new investments, inadequate return of capital on the Company’s investments, distraction of management from current operations, and unidentified issues not discovered in its due diligence of such strategies and offerings that could cause the Company to fail to realize the anticipated benefits of such investments and incur unanticipated liabilities. Because these new ventures are inherently risky, no assurance can be given that such strategies and offerings will be successful and will not adversely affect the Company’s reputation, financial condition, and operating results.

The Company and its suppliers and manufacturers are subject to a number of existing laws, regulations and industry initiatives and the regulatory environment of the healthcare industry is continuing to change. If it is determined that wethe Company or ourits suppliers or manufacturers are not in compliance with the laws and regulations to which wethey are respectively subject, ourthe Company’s business, financial condition and results of operations may be adversely affected.

As a participant in the healthcare industry, ourthe Company’s operations and relationships, and those of ourthe Company’s customers, are regulated by a number of federal, state, local, and localforeign governmental entities, and ourthe Company’s products must be capable of being used by ourits customers in a manner that complies with those laws and regulations. Because of ourits business relationships with physicians and professional healthcare providers, and since our product,its products Lumega-Z isand GlaucoCetin are believed to be a medical foodfoods and the MapcatSF and the CSV-1000, CSV-2000 and ESV-3000 are medical devices, a number of regulations are implicated. For example, from the FDA’s perspective, a drug cures, treats, or mitigates the effects or symptoms of a specific disease. A medical food manages a specific disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation. While we believethe Company believes Lumega-Z is aand GlaucoCetin are medical food,foods, if the FDA was to determinedetermines Lumega-Z or GlaucoCetin to be a drug, the Company and the product would be subject to considerable additional FDA regulation. Similarly, while we believethe Company believes the MapcatSF is a safe medical device, with a very low potential risk of injury to a patient, we believethe Company believes the MapcatSF is correctly classified as a Class I medical device, which does not require any premarket approval. The Company also believes the CSV-2000 is a Class I medical device. The CSV-1000 and ESV-3000 are currently classified with the FDA as Class I medical devices. If, however, the FDA were to determine that the MapcatSF, the CSV-1000, CSV-2000 or ESV-3000 is a Class II medical device, the Company and the particular product or products would be subject to considerable additional regulatory requirements.

The NutriGuard line of products are nutraceuticals and are regulated as dietary supplements under the Dietary Supplement, Health and Education Act of 1994 (“DSHEA”). Although dietary supplements are considered a separate regulatory category of food from consumer food products and medical foods, the FDA requires facilities that manufacture nutraceuticals to comply with regulations for current good manufacturing practices (“cGMP”). The Company does not manufacture any of the medical foods or nutraceuticals internally. The Company relies on contract manufacturers to manufacture the products. The FDA cGMP regulations largely are applicable to the site where the product is manufactured. Thus, the Company depends on the contract manufacturers to maintain cGMP compliance.

In addition, wethe Company cannot anticipate how changes in regulations or determinations by regulatory agencies may evolve. Thus, application of many foreign, state and federal regulations to ourthe Company’s business operations is uncertain. Further, there are federal and state fraud and abuse laws, including anti-kickback laws and limitations on physician referrals and laws related to off-label promotion of prescription drugs that may or may not be directly or indirectly applicable to ourthe Company’s operations and relationships or the business practices of ourits customers. It is possible that a review of ourits business practices or those of ourits customers by courts or regulatory authorities could result in a determination that may adversely affect us.the Company. In addition, the healthcare regulatory environment may change in a way that restricts our existing operations or our growth. The healthcare industry is expected to continue to undergo significant changes for the foreseeable future, which could have an adverse effect on ourthe Company’s business, financial condition and results of operations. WeThe Company cannot predict the effect of possible future legislation and regulation.

WeThe Company may be subject to fines, penalties, injunctions and other sanctions if we areit is deemed to be promoting the use of ourits products as a drug.

OurThe Company’s business and future growth depend on the development, use and ultimate sale of products that are subject to FDA regulation, clearance and approval. Under the U.S. Federal Food, Drug, and Cosmetic Act and other laws, we arethe Company is prohibited from promoting ourits products for treatment of a condition or disease. This means that wethe Company may not make claims about the usefulness or effectiveness or expected outcome of use of ourits products for any particular condition or disease and may not proactively discuss or provide information on the use of ourits products, except as allowed by the FDA.

There is a risk that the FDA or other federal or state law enforcement authorities could determine that the nature and scope of our sales and marketing activities may constitute the promotion of our products for use as a drug in violation of applicable law. WeThe Company also facefaces the risk that the FDA or other regulatory authorities might pursue enforcement based on past activities that we havethe Company discontinued or changed, including sales activities, arrangements with institutions and doctors, educational and training programs and other activities.

Government investigations are typically expensive, disruptive, burdensome and generate negative publicity. If ourits promotional activities are found to be in violation of applicable law or if we agreethe Company agrees to a settlement in connection with an enforcement action, wethe Company would likely face significant fines and penalties and would likely be required to substantially change ourits sales, promotion and educational activities. In addition, were any enforcement actions against usthe Company or ourits senior officers to arise, wethe Company could be excluded from participation in U.S. government healthcare programs such as Medicare and Medicaid.

Lumega-Z or GlaucoCetin may not qualify as a medical food as defined by the FDA.

If the FDA makes a determination that Lumega-Z or GlaucoCetin should not be defined as a medical food (and does not qualify as a drug), wethe Company would need to relabel and rebrand that product. While reclassification and the subsequent relabeling and rebranding would be an added cost to operations, it would not change the use or effectiveness of Lumega-Z.Lumega-Z or GlaucoCetin. Although, Managementmanagement believes it is unlikely the FDA would make such a determination, there is a chance that certain physicians may choose not to recommend Lumega-Z or GlaucoCetin to their patients or that certain consumers may choose not to buy Lumega-Z or GlaucoCetin if it is not classified as a medical food. While there is no insurance coverage for Lumega-Z or GlaucoCetin as a medical food, if insurance companies would otherwise pay for Lumega-Z or GlaucoCetin because of it being a medical food, a determination by the FDA that Lumega-Z or GlaucoCetin should not be defined as a medical food could limit or eliminate such potential insurance coverage which might adversely impact the sales of Lumega-Z.Lumega-Z or GlaucoCetin.

The Company’s products may cause undesirable side effects or have other properties that could delay or prevent any required regulatory approval, limit the commercial potential or result in significant negative consequences following any potential marketing approval.

If the Company’s products, including Lumega-Z, GlaucoCetin or the recently acquired NutriGuard line of products, are associated with undesirable side effects or have characteristics that are unexpected, the Company may need to abandon its development or limit development to certain uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective. Any serious adverse or undesirable side effects identified during the development of its products, could interrupt, delay or halt commercialization and/or could result in the additional regulatory requirements by the FDA or other regulatory authorities, and in turn prevent the Company from commercializing its product candidates and generating revenues from their sale.

A key part of ourthe Company’s business strategy is to establish collaborative relationships to commercialize and develop ourits product candidates. WeThe Company may not succeed in establishing and maintaining collaborative relationships, which may significantly limit ourits ability to develop and commercialize ourits products successfully, if at all.

A key part of ourthe Company’s business strategy is to establish collaborative relationships to commercialize and fund development of ourits product candidates. We areThe Company is currently a party to several collaborative relationships. The Illinois College of Optometry, for example, has included the MapcatSF prototype in its curriculum to instruct students on how to measure the macular pigment. The New York Eye and Ear Infirmary is currently evaluating Lumega-Z on glaucoma patients. The Rosenberg School of Optometry at the University of the Immaculate Word is conducting research on patients with a MapcatSF prototype. Moreover, ourthe Company’s Science Advisory Board, each member of whom is displayed on the Company website, includes world renowned experts in macular carotenoids who are developing the peer review markets by conducting research and furthering the understanding of the relevance of the macular pigment in ocular health. OurThe Company’s Medical Advisors includes thought-leading clinicians in retina, glaucoma and the anterior segment of the eye, providing guidance on understanding the clinical applications of Lumega-Z and the MapcatSF and understanding the market opportunities and assisting in driving our strategic goals. Furthermore,However, there is no guarantee that wethe Company will be successful in negotiating similar collaborative relationships with regard to the CSV-1000 and ESV-3000.VectorVision medical devices.

While the Company believes that these collaborative relationships help further validate the MapcatSF and Lumega-Z, we believe these relationships are not material to the Company because none of these relationships is exclusive, there are many potential collaborative partners available, and the Company and each collaborator is free to enter into other collaborative relationships as needed. No sales of Lumega-Z are generated directly from Illinois College of Optometry because the MapcatSF is part of its teaching curriculum, and not used for direct patient care. However, the other collaborative relationships,partners, as a result of using the MapcatSF on patients, periodically put patients on Lumega-Z if a physician determines it appropriate to do so. The majority of sales of Lumega-Z primarily come from clinicians outside of these collaborative relationships.

We believe that weThe Company may not be able to negotiate collaborations on acceptable terms, if at all, and if we doit does enter into collaborations, these collaborations may not be successful. OurThe Company’s current and future success depends in part on ourits ability to enter into successful collaboration arrangements. If we arethe Company is unable to establish and maintain collaborative relationships on acceptable terms or to successfully transition terminated collaborative agreements, wethe Company may have to delay or discontinue further development of one or more of ourits product candidates, undertake development and commercialization activities at ourits own expense or find alternative sources of capital. Consequently, if we areit is unable to enter into, maintain or extend successful collaborations, ourthe Company’s business may be harmed.

Our

The Company’s long-term success may depend upon the successful development and commercialization of products other than Lumega-Z, andGlaucoCetin, the MapcatSF medical device, the VectorVision medical devices and the CSV-1000 and ESV-3000 testing devices.newly acquired NutriGuard nutraceutical business.

Our

The Company’s long-term viability and growth may depend upon the successful development and commercialization of products other than Lumega-Z, GlaucoCetin, the MapcatSF, the CSV-1000, CSV-2000 and ESV-3000 medical devices and the MapcatSF.NutriGuard product line. Product development and commercialization is very expensive and involves a high degree of risk. Only a small number of research and development programs result in the commercialization of a product. Product development is a complex time-consuming and expensivetime-consuming process. If we failthe Company fails to adequately manage the research, development, execution and regulatory aspects of new product development weit may fail to launch new products altogether.

Government agencies may establish usage guidelines that directly apply to ourthe Company’s products or proposed products or change legislation or regulations to which we arethe Company is subject.

Government usage guidelines typically address matters such as usage and dose, among other factors. Application of these guidelines could limit the use of ourthe Company’s products and products that wethe Company may develop. In addition, there can be no assurance that government regulations applicable to ourthe Company’s products or proposed products or the interpretation thereof will not change and thereby prevent the marketing of some or all of ourits products for a period of time or permanently. The FDA’s policies may change and additional government regulations may be enacted that could modify, prevent, delay or change the regulatory approval required of ourthe Company’s products. WeThe Company cannot predict the likelihood, nature or extent of adverse government regulation that may arise from future legislation or administrative action, either in the U.S. or in other countries.

Patent litigation is common in thethe pharmaceutical and biopharmaceutical industries. Any litigation or claim against usthe Company may cause usit to incur substantial costs and could place a significant strain on ourits financial resources, divert the attention of management from ourits business and harm ourthe Company’s reputation.

While we arethe Company is not a pharmaceutical or a biopharmaceutical company, as a health sciences company, ourthe Company’s medical foods or ourits medical devicedevices may come into competition with products in the medical foods and related industries, such as pharmaceuticals, biologics or dietary supplements. There has been substantial litigation in the pharmaceutical and biopharmaceutical industries with respect to the manufacture, use and sale of new products that are the subject of conflicting patent rights. For the most part, these lawsuits relate to the validity, enforceability and infringement of patents. We expect that weThe Company expects it will rely upon patents, trade secrets, know-how, continuing technological innovations and licensing opportunities to develop and maintain ourits competitive position. WeThe Company may find it necessary to initiate claims to defend ourits intellectual property rights as a result. Other parties may have issued patents or be issued patents that may prevent the sale of ourthe Company’s products or know-how or require usthe Company to license such patents and pay significant fees or royalties to produce ourits products. In addition, future patents may issue to third parties which ourthe Company’s technology may infringe. Because patent applications can take many years to issue, there may be applications now pending of which we arethe Company is unaware that may later result in issued patents that ourthe Company’s products may infringe.

Intellectual property litigation, regardless of outcome, is expensive and time-consuming, and could divert management’s attention from our business and have a material negative effect on our business, operating results or financial condition. If such a dispute were to be resolved against us, wethe Company may be required to pay substantial damages, including treble damages and attorney’s fees to the party claiming infringement if wethe Company were to be found to have willfully infringed a third party’s patent. WeThe Company may also have to develop non-infringing technology, stop selling any products we develop,it develops, cease using technology that contains the allegedly infringing intellectual property or enter into royalty or license agreements that may not be available on acceptable or commercially practical terms, if at all. OurThe Company’s failure to develop non-infringing technologies or license the proprietary rights on a timely basis could harm ourits business. Modification of any products we developthe Company develops or development of new products thereafter could require usthe Company to become subject to other requirements of the FDA and other regulatory bodies, which could be time-consuming and expensive. In addition, parties making infringement claims may be able to obtain an injunction that would prevent usthe Company from selling any products we develop,it develops, which could harm ourits business.

Our

The Company’s competitors may develop products similar to Lumega-Z,the Company’s medical foods, and wethe Company may therefore need to modify or alter ourits business strategy, which may delay the achievement of ourits goals.

Competitors may develop products with similar characteristics to Lumega-Z.Lumega-Z or GlaucoCetin. Such similar products marketed by larger competitors could hinder ourthe Company’s efforts to penetrate the market. As a result, wethe Company may be forced to modify or alter ourits business and regulatory strategy and sales and marketing plans, as a response to changes in the market, competition and technology limitations, among others. Such modifications may pose additional delays in achieving ourthe Company’s goals.

OurThe Company’s competitors may develop products similar to the CSV-1000MapcatSF medical device, and ESV-3000 devices, and wethe Company may therefore need to modify or alter ourits business strategy, which may delay the achievement of ourits goals.

While the Company believes the MapcatSF is the only device available that can accurately measure the density of the macular pigment, competitors may develop products with similar characteristics to the Company’s MapcatSF medical device. Such similar products marketed by larger competitors could hinder the Company’s efforts to develop the market. As a result, the Company may be forced to modify or alter its business and regulatory strategy and sales and marketing plans, as a response to changes in the market, competition and technology limitations, among others. Such modifications may pose additional delays in achieving the Company’s goals.

The Company’s competitors may develop products similar to the VectorVision medical devices, and the Company may therefore need to modify or alter its business strategy, which may delay the achievement of its goals.

While we believethe Company believes that VectorVision is the only company that offers fully standardized vision testing products that ensure consistent, repeatable and highly accurate results, its competitors may introduce similar products that may compete with the CSV-1000, CSV-2000 and ESV-3000 devices. These devices offer auto-calibrated tests to ensure the correct testing luminance and contrast levels for consistent, highly accurate and repeatable results, which is why the VectorVision instruments can detect and quantify subtle changes in vision, and why the VectorVision CSV-1000 instrument is used by eye doctors in more than 60 countries to accomplish contrast sensitivity testing. The Company believes the CSV-2000 will be received well in the marketplace, although there is no assurance introduction of the instrument will be successful. For the same reasons, the Company believes that the ESV-3000 ETDRS testing device will become the worldwide standard for ETDRS visual acuity testing. The Company’s research has revealed no competing products that offers auto-calibration of ambient illumination. Competitive devices do not allow for variations in ambient light levels, resulting in variability of test results due to the environment in which the testing is performed. The CSV-1000, CSV-2000 and ESV-3000 use self-calibrated test lighting. The self-calibrated test lighting is proprietary, and the test faces of the CSV-1000 are proprietary and the intellectual property is protected under copyright and trade secret law. Both CSV-1000 and ESV-3000 are currently sold worldwide, and the Company expects this global distribution to continue. The Company is preparing to launch the CSV-2000. There is a training requirement in incorporating the CSV-1000 deviceand CSV-2000 devices into clinical practice, which the Company plans to provide as part of its commercialization strategy. Competitors currently exist, and while the Company believes its market penetration and intellectual property protection are barriers to entry, competitors may invent around the Company’s intellectual property or otherwise overcome barriers to entry and introduce similar products to compete with either the CSV-1000 or ESV-3000.these VectorVision devices.

The Company’s competitors may develop products similar to the NutriGuard product line, and the Company may therefore need to modify or alter its business strategy, which may delay the achievement of its goals.

Competitors may develop products with similar characteristics to NutriGuard products. In fact, the dietary supplement and nutraceutical markets characteristically have many companies with several similar products competing for the same market share. Such similar products marketed by larger competitors could hinder the Company’s efforts to penetrate the market. As a result, the Company may be forced to modify or alter its business and regulatory strategy and sales and marketing plans, as a response to changes in the market, competition and technology limitations, among others. Such modifications may pose additional delays in achieving the Company’s goals.

The Company’s failure to compete successfully could cause its revenue or market share to decline.

The market for our products and services is competitive and is characterized by rapidly evolving industry standards, technology and user needs and the frequent introduction of new products and services. Some of our competitors, which include major pharmaceutical companies with alternatives to our products, may be more established, benefit from greater name recognition and have substantially greater financial, technical and marketing resources than us. We compete on the basis of several factors, including distribution of products, reputation, scientific validity, reliability, client service, price, and industry expertise and experience. There can be no assurance that we will be able to compete successfully against current and future competitors or that the competitive pressures that we face will not materially adversely affect our business, financial condition and results of operations.

If we arethe Company is unable to develop ourits own sales, marketing and distribution capabilities, or if we areit is not successful in contracting with third parties for these services on favorable terms, or at all, revenues from any products we developproduct sales could be limited.

WeThe Company currently havehas limited sales, marketing and distribution capabilities. To commercialize our products successfully, we have to develop more robust capabilities internally or collaborate with third parties that can perform these services for us. In the process of commercializing our products, we may not be able to hire the necessary experienced personnel and build sales, marketing and distribution operations capable of successfully launching new products and generating sufficient product revenues. In addition, establishing such operations takes time and involves significant expense.

If we decidethe Company decides to enter into co-promotion or other licensing arrangements with third parties, we may be unable to identify acceptable partners because the number of potential partners is limited and because of competition from others for similar alliances with potential partners. Even if we are able to identify one or more acceptable partners, we may not be able to enter into any partnering arrangements on favorable terms, or at all. If we enter into any partnering arrangements, our revenues are likely to be lower than if we marketed and sold our products ourselves.

In addition, any revenues we receivethe Company receives would depend upon our partners’ efforts which may not be adequate due to lack of attention or resource commitments, management turnover, and change of strategic focus, further business combinations or other factors outside of our control. Depending upon the terms of our agreements, the remedies we have against an under-performing partner may be limited. If we were to terminate the relationship, it may be difficult or impossible to find a replacement partner on acceptable terms, or at all.

If wethe Company cannot compete successfully for market share against other companies, weit may not achieve sufficient product revenues and ourits business will suffer.

The market for our products and product candidates is characterized by competition and technological advances. If our products are unable to capture and maintain market share, we may not achieve sufficient product revenues and our business will suffer.

We will compete for market share against fully integrated medical food and medical device companies or other companies that develop products independently or collaborate with larger pharmaceutical companies, academic institutions, government agencies and other public and private research organizations. In addition, many of these competitors, either alone or together with their collaborative partners, have substantially greater capital resources, larger research and development staffs and facilities, and greater financial resources than we do, as well as significantly greater experience in:

Our competitors may:

If we are unable to compete successfully against current or future competitors, we may be unable to obtain market acceptance for any product candidates that we create, which could prevent us from generating revenues or achieving profitability and could cause the market price of our common stock to decline.

Product liability lawsuits against the Company could divert its resources and could cause it to incur substantial liabilities and to limit commercialization of Company products.

We face a risk of product liability exposure related to the use of our products, including Lumega-Z, GlaucoCetin and the NutriGuard product line of nutraceuticals. If we cannot successfully defend ourselves against claims that our product candidates or products caused injuries, we will incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

Our insurance policies may not fully cover liabilities that we may incur in the event of a product liability lawsuit. We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.

WeThe Company may be unsuccessful in expanding ourits product distribution outside the United States.

To the extent we begin to offer our products outside the United States, we expect that we may be dependent on third-party distribution relationships. Distributors may not commit the necessary resources to market and sell our products to the level of our expectations. If distributors do not perform adequately, or we are unable to locate distributors in particular geographic areas, our ability to realize long-term international revenue growth would be materially adversely affected.

Additionally, our products may require regulatory clearances and approvals from jurisdictions outside the United States. We expect that we will be subject to and required to comply with local regulatory requirements before selling our products in those jurisdictions. We are not certain that we will be able to obtain these clearances or approvals or compliance requirements on a timely basis, or at all.

Manufacturing risks and inefficiencies may adversely affect ourthe Company’s ability to produce products.

We engage third parties to manufacture our products in sufficient quantities and on a timely basis, while maintaining product quality, and acceptable manufacturing costs and complying with regulatory requirements. In determining the required quantities of our products and the manufacturing schedule, we must make significant judgments and estimates based on historical experience, inventory levels, current market trends and other related factors. Because of the inherent nature of estimates, there could be significant differences between our estimates and the actual amounts of products we require. If we are unable to obtain from one or more of our vendors the needed materials or components that meet our specifications on commercially reasonable terms, or at all, we may not be able to meet the demand for our products. WeWhile we have not arranged for alternate suppliers, and it may be difficult to find alternate suppliers in a timely manner and on terms acceptable to us.us, we believe that there are multiple alternative sources, suppliers and manufacturers available for our products and devices in the event of a termination or a disagreement with any current vendor.

Security breaches and other disruptions could compromise ourthe Company’s information and expose usit to liability, which would cause ourits business and reputation to suffer.

In the ordinary course of our business, we collect and store sensitive data, including intellectual property, our proprietary business information and that of our customers and business partners, including personally identifiable information of our customers, some of which is stored on our network and some of which is stored with our third-party E-commerce vendor. Despite our security measures, our information technology and infrastructure may be vulnerable to attacks by hackers or breached due to operator error, malfeasance or other disruptions. Any such breach could compromise our network and the information stored there could be accessed, publicly disclosed, lost or stolen. Any such access, disclosure or other loss of information could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, disrupt our operations, and damage our reputation, which could adversely affect our business.

OurThe Company’s products and facility and the facilities of ourits manufacturers are subject to federal laws and regulations and certain requirements in the State of California. Failure to comply with any law or regulation could result in penalties and restrictions on ourthe Company’s manufacturers’ ability to manufacture and ourthe Company’s ability to distribute products. If any such action were to be imposed, it could have a material adverse effect on ourthe Company’s business and results of operations.

Although medical foods do not require pre-market approval by the FDA, manufacturers of medical foods must be registered with the FDA under a provision promulgated by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the “Bioterrorism “Bioterrorism Act”).Manufacturers of medical foods are subject to periodic inspection by the FDA. The manufacture of our medical foods is outsourced in its entirety to athree third-party manufacturer.manufacturers. We are evaluating additional manufacturers for selection as second source or back-up providers. Our medical foods have not been reviewed by the FDA. There is no certainty that the FDA will favorably review our medical food products or our manufacturers’ facilities. If the outcome of an inspection is negative or if we or our manufacturers fail to comply with any law or regulation, we could be subject to penalties and restrictions on our manufacturers’ ability to manufacture and distribute products. Any such action may result in a material adverse effect on our business and results of operations. For a more complete discussion of the laws and regulations to which we are subject, see the section of this reportprospectus titled “Description of Business“Business - Government Regulation.Regulation.”

Prior to the acquisition of VectorVision, all of the Company’s billings and revenues have been derived from the sale of a single product.

For the nine months ended September 30, 2017 as well as the years ended December 31, 20162018 and 2015,2017, the Company derived 100%a portion of its revenues from the sale of Lumega-Z®. While we continue to see an increasing demand for Lumega-Z from our customers, we cannot assure you that the demand will continue. A decline in sales of Lumega-Z to our customers may have an immediate adverse effect on our financial results. After September 30, 2017,The Company began recognizing revenue from our VectorVision acquisition in the fourth quarter of 2017. Although the Company expects to continue to realize revenues from sales of the CSV-1000 orand ESV-3000 products, however, there is no assurance that such sales will continue at historical levels or that any of our products will otherwise continue to be commercially viable.viable and in fact they are expected to be less than revenue from the prior quarter and prior year similar quarter. Although the CSV-1000 will continue to be sold, the Company plans to put a greater focus on sales and marketing efforts of the new CSV-2000 beginning in the fourth quarter of 2019. There can be no assurances that the marketing efforts will be successful and sales of the CSV-2000 will be comparable or exceed sales of the CSV-1000. The Company recently launched its second medical food, GlaucoCetin. The Company recently acquired the NutriGuard business.

The Company’s billings and revenues are derived from a limited number of customers and the loss of any one or more of them may have an immediate adverse effect on ourits financial results.

For the nine months ended September 30, 2017 as well asIn the years ended December 31, 20162018 and 2015,2017, the Company’s billings were derived from a limited number of individual customers. The Company does not receive volume commitments from its customers.customers and distributors. Customers may stop purchasing our products with little or no warning. After September 30, 2017, the Company expects to encounter additional customers due to sales of the CSV-1000 and ESV-3000 products. However, VectorVision also does not receive volume commitments from its customers. Customers may stop purchasing CSV-1000 or ESV-3000 products with little or no warning. Loss of customers may have an immediate adverse effect on our financial results.

If we arethe Company is forced to reduce ourits prices, ourits business, financial condition and results of operations may suffer.

WeThe Company may be subject to pricing pressures with respect to ourits future sales arising from various sources, including practices of health insurance companies, healthcare providers and competition in the marketplace. If ourthe Company’s pricing experiences significant downward pressure, our business could be less profitable and our results of operations may be adversely affected. In addition, because cash from sales funds our working capital requirements, reduced profitability could require us to raise additional capital to support our operations.

If we arethe Company is unable to successfully introduce new products or failfails to keep pace with medical advances and developments, ourits business, financial condition and results of operations may be adversely affected.

The successful implementation of our business model depends on our ability to adapt to evolving technologies and industry standards and introduce new products and services. We cannot assure you that we will be able to introduce new products on schedule, or at all, or that such products will achieve market acceptance. Moreover, competitors may develop competitive products that could adversely affect our results of operations. A failure by us to introduce planned products or other new products or to introduce these products on schedule may have an adverse effect on our business, financial condition and results of operations.

In addition, introduction of a new product that has similar or advances features over a current product may reduce interest and sales in the current product. There is no assurance that a new product will achieve the same or greater sales levels of a current product or that sales of a new product will replace or exceed the sales of a current product.

If we cannot adapt to changing technologies, our products and services may become obsolete, and our business could suffer. Because the healthcare industry is characterized by rapid technological change, we may be unable to anticipate changes in our current and potential customers’ requirements that could make our existing technology obsolete. Our success will depend, in part, on our ability to continue to enhance our existing products, develop new technology that addresses the needs of our prospective customers, license leading technologies and respond to technological advances and emerging industry standards and practices on a timely and cost-effective basis. The development of our proprietary technology entails significant technical and business risks. We may not be successful in using new technologies effectively or adapting our proprietary technology to evolving customer requirements or emerging industry standards, and, as a result, our business may suffer.

If customers do not accept ourthe Company’s products or delay in deciding whether to recommend ourthe Company’s products and services, ourits business, financial condition and results of operations may be adversely affected.

Our business model depends on our ability to sell our products. Acceptance of our products requires physicians to use our MapcatSF to measure the macular protective pigment in their patients’ eyes, understand and appreciate the benefits of Lumega-Z in order to recommend it to their patients, and to understand the benefits of visual acuity testing so that they orderusing the CSV-1000, orCSV-2000 and ESV-3000 devices. We cannot assure you that physicians will integrate our products into their treatment plans or patient recommendations. Achieving market acceptance for our products and services will require substantial sales and marketing efforts and the expenditure of significant financial and other resources to create awareness and demand by participants in the healthcare industry. If we fail to achieve broad acceptance of our products by physicians, and other healthcare industry participants or if we fail to position our products as an ocular health remedy, our business, financial condition and results of operations may be adversely affected.

If ourthe Company’s principal suppliers fail or are unable to perform their contracts with us, wethe Company, it may be unable to meet ourits commitments to ourits customers. As a result, ourthe Company’s reputation and ourits relationships with ourits customers may be damaged and ourits business and results of operations may be adversely affected.

We currently purchase all our medical food ingredients and products from three vendors – one for carotenoids, one for Omega 3, and one for all other supplements. All of the ingredients for the nutraceutical products are sourced by the contract manufacturer that produces the NutriGuard products. These companies are subject to FDA regulation and they are responsible for compliance with current Good Manufacturing Practices (“cGMP” as defined by the FDA). Although our agreements provide that our suppliers will abide by the FDA manufacturing requirements, we cannot control their compliance. If they fail to comply with FDA manufacturing requirements, the FDA could prevent our vendors from manufacturing our ingredients and products. Although we believe that there are a number of other sources of supply of ingredients and manufacturers of medical food products, if these suppliers are unable to perform under our agreements, particularly at certain critical times such as when we add new physician clients that will require a large production of one or more products, we may be unable to meet our commitments to our customers. If this were to happen, our reputation as well as our relationships with our customers may suffer and our business and results of operations may be adversely affected. We are evaluating several additional manufacturers for selection as second source or back-up providers.

If we incurthe Company incurs costs exceeding ourits insurance coverage in lawsuits that are brought against usit in the future, it would be expected tosuch incident may adversely affect ourthe Company’s business, financial condition and results of operations.

If we were to become a defendant in any lawsuits involving the manufacture and sale of our products and if our insurance coverage were inadequate to cover or satisfy these liabilities, it would be expected to have an adverse effect on our business, financial condition and results of operations.

If we arethe Company is deemed to infringe on the proprietary rights of third parties, weit could incur unanticipated expense and be prevented from providing ourits products and services.

We could be subject to intellectual property infringement claims as the number of our competitors grows and if our products or the functionality of our products overlap with patents of our competitors. While we do not believe that we have infringed or are infringing on any proprietary rights of third parties, we cannot assure you that infringement claims will not be asserted against us or that those claims will be unsuccessful. We could incur substantial costs and diversion of management resources defending any infringement claims whether or not such claims are ultimately successful. Furthermore, a party making a claim against us could secure a judgment awarding substantial damages, as well as injunctive or other equitable relief that could effectively block our ability to provide products or services. In addition, we cannot assure you that licenses for any intellectual property of third parties that might be required for our products or services will be available on commercially reasonable terms, or at all.

OurThe Company’s business depends on ourits intellectual property rights, and if we areit is unable to protect them, ourits competitive position may suffer.

Our business plan is predicated on our proprietary technology. Accordingly, protecting our intellectual property rights is critical to our continued success and our ability to maintain our competitive position. Our goal is to protect our proprietary rights through a combination of patent, trademark, trade secret and copyright law, confidentiality agreements and technical measures. We generally enter into non-disclosure agreements with our employees and consultants and limit access to our trade secrets and technology. We cannot assure you that the steps we have taken will prevent misappropriation of our technology. Misappropriation of our intellectual property would have an adverse effect on our competitive position.

The Company has onefour issued patentpatents and threefive pending patent applications related to its products. There currently are no issued patents relating to Lumega-Z and the CSV-1000 and EVS-3000 devices.Lumega-Z. Our success, competitive position, and future revenues will depend, in part, on our ability to obtain and maintain patent protection for our products, methods, processes, and other technologies; to preserve our trade secrets; to obtain trademarks for our name, logo and products; to prevent third parties from infringing our proprietary rights; and to operate without infringing the proprietary rights of third parties. To counter infringement or unauthorized use by third parties, we may be required to file infringement claims, which can be expensive and time-consuming. If we infringe the rights of third parties, we could be prevented from selling our products, forced to pay damages, and forced to incur substantial costs in defending litigations.

The patent process is subject to numerous risks and uncertainties, and there can be no assurance that we will be successful in protecting our products by obtaining and defending patents. These risks and uncertainties include the following:

In addition, the USPTO, and patent offices in other jurisdictions have often required that patent applications concerning pharmaceutical and/or biotechnology-related inventions be limited or narrowed substantially to cover only the specific innovations exemplified in the patent application, thereby limiting the scope of protection against competitive challenges. Thus, even if we or any of our licensors are able to obtain patents, the patents may be substantially narrower than anticipated.

OurThe Company’s business depends in part on and will continue to depend in part on ourits ability to establish and maintain additional strategic collaborative relationships. Our failureFailure to establish and maintain these relationships could make it more difficult to expand the reach of ourthe Company’s products, which may have a material adverse effect on ourits business.

To be successful, we must continue to maintain our existing strategic relationships, such as our relationship with our vendors who manufacture our medical food products. We also must continue to establish additional strategic relationships with healthcare leaders. This is critical to our success because we believe that these relationships contribute towards our ability to extend the reach of our products and services to a larger number of physicians, professional healthcare providers and physician groups and to other participants in the healthcare industry; develop and deploy new products and services; and generate additional revenue and cash flows. Entering into strategic relationships is complicated because strategic partners may decide to compete with us in some or all of our markets. In addition, we may not be able to maintain or establish relationships with key participants in the healthcare industry if we conduct business with their competitors.

WeThe Company must attract quality management in order to manage ourits growth. Failure to do so may result in slower expansion.

In order to support the growth of our business and the additional obligations that come with being an exchange-listed company, we will need to expand our senior management team. We plan to recruit additional personnel, including a Chief Financial Officer and a Chief Operating Officer in the near future. There is no assurance that we will be capable of attracting and retaining quality managersexecutives and integrating those individuals into our management system. Without experienced and talented management, the growth of our business may be adversely impacted.

Competition for qualified employees is intense, and weintense. The Company may not be able to attract and retain the highly skilled employees we needneeded to support ourits business. Without skilled employees, the quality of ourits product development and services could diminish and the growth of ourits business may be slowed, which could have a material adverse effect on ourthe Company’s business, financial condition and results of operations.

Our ability to provide high-quality products and services to our clients depends, in large part, upon our employees’ experience and expertise. We must attract and retain highly qualified personnel with a deep understanding of the pharmaceutical and healthcare information technology industries. In addition, we will invest significant time and expense in training our employees, increasing their value to clients as well as to competitors who may seek to recruit them, which will increase the cost of replacing them. If we fail to retain our employees, the quality of our product development and services could diminish and the growth of our business may be slowed. This may have a material adverse effect on our business, financial condition and results of operations.

If we losethe Company loses the services of ourits Chief Executive Officer and other key personnel, weit may be unable to replace them, and ourthe Company’s business, financial condition and results of operations may be adversely affected.

Our success largely depends on the continued skills, experience, efforts and policies of our management team and other key personnel and our ability to continue to attract, motivate and retain highly qualified employees. In particular, the services of Michael Favish, our founder, President and Chief Executive Officer, and David Evans, director of the Company and Chief ExecutiveScience Officer, of VectorVision, are integral to the execution of our business strategy. We believe that the loss of the services of Mr. Favish or Dr. Evans could adversely affect our business, financial condition and results of operations. We cannot assure you that Mr. Favish, Dr. Evans or our other executive officers will continue to provide services to the Company. We do not maintain key man insurance for any of our key personnel.

The Company’s ability to attract and retain qualified members of our board of directors may be impacted due to new state laws, including recently enacted gender quotas.

Our failureIn September 2018, California enacted SB 826 requiring public companies headquartered in California to compete successfully could cause our revenuemaintain minimum female representation on their boards of directors as follows: by the end of 2019, at least one woman on its board, by the end of 2020, public company boards with five members will be required to have at least two female directors, and public company boards with six or market sharemore members will be required to decline.have at least three female directors. Failure to achieve designated minimum levels in a timely manner exposes such companies to financial penalties and reputational harm. We cannot assure that we can recruit, attract and/or retain qualified members of the board and meet gender quotas as a result of the California law, which may expose us to penalties and/or reputational harm.

The market for our products and services is competitive and is characterized by rapidly evolving industry standards, technology and user needs and the frequent introduction of new products and services. Some of our competitors, which include major pharmaceutical companies with alternatives to our products, may be more established, benefit from greater name recognition and have substantially greater financial, technical and marketing resources than us. We compete on the basis of several factors, including distribution of products, reputation, scientific validity, reliability, client service, price, and industry expertise and experience. There can be no assurance that we will be able to compete successfully against current and future competitors or that the competitive pressures that we face will not materially adversely affect our business, financial condition and results of operations.

OurCompany’s future success depends upon ourits ability to grow, and if we aregrow. If the Company is unable to manage ourits growth effectively, weit may incur unexpected expenses and be unable to meet ourits customers’ requirements.

We will need to expand our operations if we successfully achieve market acceptance for our products and services. We cannot be certain that our systems, procedures, controls and existing space will be adequate to support expansion of our operations. Our future operating results will depend on the ability of our officers and key employees to manage changing business conditions and to implement and improve our technical, administrative, financial control and reporting systems. We may not be able to expand and upgrade our systems and infrastructure to accommodate these increases.increases or we may not have the qualified personnel to implement them. Difficulties in managing any future growth could have a significant negative impact on our business, financial condition and results of operations because we may incur unexpected expenses and be unable to meet our customers’ requirements.

WeThe Company may consider acquiring other companies or product lines in an effort to expand ourits business in exchange for cash and/or stock of the Company (or a combination thereof), which may not be successful or which may cause dilution to investors.

The Company will consider acquiring other companies or product lines that may be complementary or supplementary as part of our future efforts to expand the business, which acquisitions could be for cash, stock or a combination thereof. In either event, thereThere is no guarantee that any such acquisition will be successful or that an acquired company’s products, operations or corporate culture will mesh with our Company, integrate well, or that any economies of scale will be realized. In addition, any such transaction that involves the Company’s stock would cause dilution to investors. In addition, any such transaction that involves cash would result in a reallocation of funds on hand that would be needed to support an acquired company or acquired product line.

In order to expand ourthe Company’s business into additional states, weit may need to comply with regulatory requirements specific to such states and there can be no assurance that weit will be able to initially meet such requirements or that weit will be able to maintain compliance on an on-going basis.

While we believe our product, Lumega-Z^®Lumega-Z®, to be a medical food and not a drug, it is only available under the supervision of a physician. While it is not available in pharmacies, we are mindful that the act of physicians prescribing, particularly if conducted across state lines, could potentially be subject to certain pharmacy regulations. Each state has its own regulations concerning physician dispensing, restrictions on the corporate practice of medicine, anti-kickback and false claims. In addition, each state has a board of pharmacy that regulates the sale and distribution of drugs and other therapeutic agents. Some states require a physician to obtain a license to dispense prescription products. While we do not believe these pharmacy requirements are applicable should a pharmacy board or medical board determine otherwise, there can be no assurance that we will be able to comply with the regulations of particular states into which we may expand or that we will be able to maintain compliance with the states in which we currently distribute our products. We currently have Lumega-Z customers in California, Massachusetts, Connecticut, New York, Pennsylvania, New Jersey, Georgia, North Carolina, South Carolina, Florida, Kentucky, Tennessee, Kansas, Indiana, Illinois, Minnesota, Oklahoma, Texas, New Mexico, Mississippi, Idaho, Utah, Nevada, Arizona, Washington, Hawaii and Alberta, Canada. Our inability to maintain compliance with the regulations of California and these other jurisdictions or expand our business into additional states may adversely affect our results of operations.

The Company is subject to anti-corruption laws, as well as export control laws, customs laws, sanctions laws and other laws governing our operations. If it fails to comply with these laws, it could be subject to civil or criminal penalties, other remedial measures and legal expenses, be precluded from developing manufacturing and selling certain products outside the U.S. or be required to develop and implement costly compliance programs, which could adversely affect its business, results of operations and financial condition.

Our operations are subject to anti-corruption laws, including the U.K. Bribery Act 2010, or Bribery Act, the U.S. Foreign Corrupt Practices Act, or FCPA, and other anti-corruption laws that apply in countries where we do business and may do business in the future. The Bribery Act, FCPA and these other laws generally prohibit us, our officers, and our employees and intermediaries from bribing, being bribed or making other prohibited payments to government officials or other persons to obtain or retain business or gain some other business advantage. Compliance with the FCPA, in particular, is expensive and difficult, particularly in countries in which corruption is a recognized problem. In addition, the FCPA presents particular challenges in the pharmaceutical industry, because, in many countries, hospitals are operated by the government, and doctors and other hospital employees are considered foreign officials. Certain payments to hospitals in connection with clinical trials and other work have been deemed to be improper payments to government officials and have led to FCPA enforcement actions.

We may in the future operate in jurisdictions that pose a high risk of potential Bribery Act or FCPA violations, and we may participate in collaborations and relationships with third parties whose actions could potentially subject us to liability under the Bribery Act, FCPA or local anti-corruption laws. In addition, we cannot predict the nature, scope or effect of future regulatory requirements to which our international operations might be subject or the manner in which existing laws might be administered or interpreted. If we expand our operations outside of the U.S., we will need to dedicate additional resources to comply with numerous laws and regulations in each jurisdiction in which we plan to operate.

We are also subject to other laws and regulations governing our international operations, including regulations administered by the governments of the United Kingdom and the U.S., and authorities in the European Union, including applicable export control regulations, economic sanctions on countries and persons, customs requirements and currency exchange regulations, collectively referred to as the Trade Control laws. In addition, various laws, regulations and executive orders also restrict the use and dissemination outside of the U.S., or the sharing with certain non-U.S. nationals, of information classified for national security purposes, as well as certain products and technical data relating to those products. If we expand our presence outside of the U.S., it will require us to dedicate additional resources to comply with these laws, and these laws may preclude us from developing, manufacturing, or selling certain products and product candidates outside of the U.S., which could limit our growth potential and increase our development costs.

We may not be completely effective in ensuring our compliance with all applicable anti-corruption laws, including the Bribery Act, the FCPA or other legal requirements, including Trade Control laws. If we are not in compliance with the Bribery Act, the FCPA and other anti-corruption laws or Trade Control laws, we may be subject to criminal and civil penalties, disgorgement and other sanctions and remedial measures, and legal expenses, which could have an adverse impact on our business, financial condition, results of operations and liquidity. The Securities and Exchange Commission also may suspend or bar issuers from trading securities on U.S. exchanges for violations of the FCPA’s accounting provisions. Any investigation of any potential violations of the Bribery Act, the FCPA, other anti-corruption laws or Trade Control laws by U.K., U.S. or other authorities could also have an adverse impact on our reputation, our business, results of operations and financial condition.

OurThe Company’s Second Amended and Restated Bylaws have andesignates the Court of Chancery of the State of Delaware as the sole and exclusive forum for adjudicationcertain types of state law actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes provision which limits the forum to the Delaware Court of Chancery for certain actions against the Company.with us or our directors, officers, employees or agents.

Article XI of our Second Amended and Restated Bylaws, or our Bylaws, dictates that the Delaware Court of Chancery is the sole and exclusive forum for certain state law based actions including certain derivative actionactions or proceedingproceedings brought on behalf of the Company; an action asserting a breach of fiduciary duty owed by an officer, a director, employee or to the shareholders of the Company; any claim arising under Delaware corporate law; and any action asserting a claim governed by the internal affairs doctrine. This means a shareholder has a limited forum in which to bring one of the above causes of action, which can be inconvenient for the shareholder.

A Delaware corporation

This exclusive forum provision does not apply to suits brought to enforce any liability or duty created by the Securities Act or the Exchange Act orother federal securities laws for which there is allowed to mandate in its corporate governance documents a chosenexclusive federal or concurrent federal and state jurisdiction.

This choice of forum for the resolution of state law based shareholder class actions, derivative suits and other intra-corporate disputes. The Company’s management believes limiting state law based claims to Delaware will provide the most appropriate outcomes as the risk of another forum misapplying Delaware law is avoided. Delaware courts have a well-developed body of case law and limiting the forum will preclude costly and duplicative litigation and avoids the risk of inconsistent outcomes. It also means a shareholder’sprovision may limit our stockholders’ abilityto bring a claim in a judicial forum that it believes isfinds favorable for disputes with us or our directors, officers, employees or agents, which may discourage such lawsuits against us and our directors, officers, employees and agents even though an action, if successful, might benefit our stockholders. Stockholders who do bring a claim in the Court of Chancery could face additional litigation costs in pursuing any such claim, particularly if they do not reside in or near Delaware. The Court of Chancery may also reach different judgments or results than would other courts, including courts where a stockholder considering an action may be located or would otherwise choose to bring the action, and such judgments or results may be more favorable to shareholdersus than to our stockholders. Alternatively, if a court were to find this provision of our Bylaws inapplicable to, or unenforceable in disputesrespect of, one or more of the specified types of actions or proceedings, we may incur additional costs associated with directors, officersresolving such matters in other jurisdictions, which could have a material adverse effect on our business, financial condition or other employees is limited and may discourage shareholders from bringing such claims. Additionally, Delaware Chancery Courts can typically resolve disputes on an accelerated schedule when compared to other forums.results of operations.

The Company’s ability to realize the anticipated benefits of the new Transcranial Doppler Solutions, Inc. business will depend on its ability to attract qualified personnel and to successfully launch, market and advance a new service in an area where the Company has no experience, which may be a complex, costly and time-consuming process. The Company currently employs one individual who has experience in this area to lead the business, the loss of whom would affect the prospects of a successful launch and operation. The Company may be required to devote significant management attention and resources to develop the Transcranial Doppler Solutions, Inc. business. The initiation process may disrupt its business and, if implemented ineffectively, could restrict the realization of the full expected benefits of the new business service. The failure to meet the challenges involved in the initiation process and to realize the anticipated benefits of the new business could cause an interruption of, or a loss of momentum in, the Company’s operations and could adversely affect its business, financial condition and results of operations.

Risks Related to the Company’s Industry

Any failure to comply with all applicable federal and state confidentialityprivacy and security requirements for the protection of patient information may result in fines and other liabilities, which may adversely affect ourthe Company’s results of operations.operations and reputation.

When a physician recommends our medical food, Lumega-Z, to a patient we typically receive an order from the customer, but we do not usually receive medical information. As part of the operation of our business, it is possible, however, that during communication with customers or with physicians we might receive patient-identifiable medical information. The Health Insurance Portability and Accountability Act of 1996, Pub. L. No. 104-191 (“HIPAA”), the Health Information Technology for Economic and Clinical Health Act, Title XIII of the American Recovery and Reinvestment Act of 2009 (the “HITECH Act”), and related regulations promulgated by the Secretary (“HIPAA Regulations”) grant a number of rights to individuals as to their identifiable confidential medical information (called “Protected Health Information”) and restrict the use and disclosure of Protected Health Information. Failure to comply with these confidentiality requirements may result in penalties and sanctions. In addition, certain state laws may impose independent obligations upon us with respect to patient-identifiable medical information. Moreover, various new laws relating to the acquisition, storage and transmission of patient medical information have been proposed at both the federal and state level. These laws (collectively, the “State and Federal Privacy and Security Laws”) present different risks as to the Company’s two lines of business: (1) our sale of medical food, Lumega-Z; and (2) our performance of Trans Cranial Doppler (“TCD”) testing.

1. Medical Food, Lumega-Z. When a physician recommends the Company’s medical food, Lumega-Z, to a patient, the Company typically receives an order from the customer, but does not usually receive medical information. As part of the operation of its business, it is possible, however, that during communication with customers or with physicians the Company might receive patient-identifiable medical information. To the extent the Company obtains access to Protected Health Information, it must ensure it complies with the State and Federal Privacy and Security Laws. Any failure to comply may result in fines and other liabilities, which may adversely affect ourits results of operations.

2. The TCD Testing Business. In the TCD Testing line-of-business, the Company will go into physicians’ offices and, as a vendor to the physicians, perform TCD tests on patients, as ordered by and under the supervision of the patients’ treating physicians. Radiologists will read and report on the results of the tests, and the results will be reported back to the ordering/treating physician. The treating physician who orders the tests bill for the TCD tests to third party payors. During this process, the Company directly interacts with patients and has access to, processes and transmits Protected Health Information. As a result, the State and Federal Privacy and Security Laws will fully apply to the TCD Testing business. As required by federal law, the Company has been putting into place a HIPAA compliance program, including providing training to staff, instituting appropriate Business Associate Agreements, implementing required policies and procedures, and conducting regular risk assessments. Any failure to comply with the requirements of the State and Federal Privacy and Security Laws – or any loss of Protected Health Information, whether inadvertent or not – may result in fines and other liabilities, which may adversely affect the Company’s results of operations.

Any failure to comply with all applicable federal and state physician self-referral law (the “Stark Law”) may result in fines and other liabilities, which may adversely affect the Company’s results of operations and reputation.

Congress enacted significant prohibitions against physician self-referrals in the Omnibus Budget Reconciliation Act of 1993. This law and its supporting regulations, which have been amended and expanded substantially, are commonly referred to as the “Stark II,Law,” appliesand prohibit a physician from making any referral of a Stark Designated Health Service (“DHS”) to an entity with which the physician dispensinghas any kind of financial relationship, unless all of the requirements of a statutory or regulatory exception are met. Stark covered DHS include both outpatient prescription drugs and diagnostic testing that are reimbursable by Medicare or Medicaid. OurMany states have similar laws, some of which can apply to all payors and not just governmental payors. While the Company believes that its arrangements with its customers are in compliance with the federal and any state Stark Laws, the Stark Laws present different levels of risks as to the Company’s two lines of business: (1) sale of the Company’s medical food, Lumega-Z, and medical device, the MapcatSF; and (2) the Company’s performance of TCD testing.

1. Medical Food, Lumega-Z, and Medical Device, the MapcatSF. These products are neither prescription drugs nor are they reimbursable under any federal program at present. Therefore, the Company believes that the federal Stark II,Law is not applicable. Further, the Company’s believes that these products are also not covered under any potentially applicable state Stark Laws. The federal Stark Law, however, includes an exception for the provision of in-office ancillary services, including a physician’s dispensing of outpatient prescription drugs, provided that the physician meets specified requirements. We believeTo the extent that the products might become reimbursable under a federal program, or otherwise become covered under the Stark Law, the Company believes that the physicians who use ourthe Company’s medical device, the MapcatSF, or recommend ourits medical food, Lumega-Z, to their patients are aware of these requirements, but we dorequirements. However, the Company does not monitor their compliance and havehas no assurance that the physicians are in material compliance with the Stark II.Law. If it were determined that the physicians who use ourthe Company’s medical device or prescribe medical foods purchased from usthe Company were not in compliance with Stark II, it could potentially have an adverse effect on ourthe Company’s business, financial condition and results of operations.

2. The TCD Testing Business. The TCD tests performed by the Company can be reimbursed by Medicare or Medicaid and otherwise constitute a Stark covered DHS, which include diagnostic testing. In conducting TCD tests, the Company will be providing the tests to the ordering physician, who will be paying TCD as a vendor to perform the test on behalf of the physician; and the physician will then be billing for the test to third party payers, including potentially Medicare and Medicaid. As a result, the tests will be considered to be an in-office ancillary service covered under Stark. The Stark Law, however, includes an exception for the provision of such in-office ancillary services, provided that the physician meets specified requirements. The Company believes that the physicians who engage the Company as a vendor to perform the TCD tests are aware of these requirements. However, the Company does not monitor the physicians’ compliance and has no assurance that the physicians are in material compliance with the Stark Law. If it were determined that the physicians were not in compliance with Stark, such could potentially have an adverse effect on the Company’s business, financial condition and results of operations.

The Company believe its current structure of its relationships with the ordering physicians to be in compliance with all of the requirements of applicable Stark Law exceptions. Any failure to comply the requirements of the Stark Law, however, may result in fines and other liabilities, which may adversely affect the Company’s results of operations, and the future operations of the TCD business could be adversely affected.

Any failure to comply with all applicable federal and state anti-kickback laws may result in fines and other liabilities, which may adversely affect the Company’s results of operations and reputation.

The federal anti-kickback statute (the “AKS”) applies to Medicare, Medicaid and other state and federal programs. At present, our products are not prescription drugs, nor are they reimbursable under any federal program. The federal anti-kickback statuteAKS prohibits the solicitation, offer, payment or receipt of remuneration in return for referrals or the purchase, or in return for recommending or arranging for the referral or purchase, of goods, including drugs, covered by the federal health care programs. At present, the Company does not participate in any federal programs and its products are not reimbursed by Medicare, Medicaid or any other state or federal program. The federal anti-kickbackAKS is a criminal statute with criminal penalties, as well as potential civil and administrative penalties. The AKS, however, provides a number of statutory exceptions and regulatory “safe harbors” for particular types of transactions. We believe that our arrangements with our customers are in material compliance with the anti-kickback statute and relevant safe harbors. Many states have similar fraud and abuse laws and we believetheir own anti-kickback laws, some of which can apply to all payors, and not just governmental payors. While the Company believes that we areit is in material compliance with those laws.both federal and state AKS laws, the AKS laws present different levels of risks as to the Company’s two lines of business: (1) sale of the Company’s medical food, Lumega-Z, and medical device, the MapcatSF; and (2) the Company’s performance of TCD testing.

1. Medical Food, Lumega-Z, and Medical Device, the MapcatSF. At present, we do not participate in any federal programs and ourthe Company’s products are not reimbursed by Medicare, Medicaid orreimbursable under any other state or federal program. If, however, that changes in the future and it were determined that we werethe Company was not in compliance with the federal anti-kickback statute, weAKS, the Company could be subject to liability, and ourits operations could be curtailed.curtailed, which could have a material adverse effect on the Company’s business, financial condition and results of operations. Moreover, if the activities of ourits customers or other entity with which we havethe Company has a business relationship were found to constitute a violation of the federal anti-kickback lawAKS and we,the Company, as a result of the provision of products or services to such customer or entity, were found to have knowingly participated in such activities, wethe Company could be subject to sanctionsanctions or liability under such laws, including civil and/or criminal penalties, as well as exclusion from government health programs. As a result of exclusion from government health programs, neither products nor services could be provided to any beneficiaries of any federal healthcare program.

2. The TCD Testing Business. The TCD tests performed by the Company can be reimbursed by Medicare or Medicaid. As a result, the federal AKS (and potentially any applicable state anti-kickback law) will be implicated to the extent the financial relationships between the physician customers and the Company are (1) not set at a fair market value amount unrelated to the volume or value of TCD tests being ordered; or (2) were found to be a circumvention of the AKS through the creation of a suspect contractual joint venture. If the Company’s arrangements with ordering physicians were found to constitute a violation of the federal AKS, or any applicable state anti-kickback law, we could be subject to sanctions or liability under such laws, including civil and/or criminal penalties, as well as exclusion from government health programs. As a result of exclusion from government health programs, neither products nor services could be provided to any beneficiaries of any federal healthcare program.

As to the TCD Testing line of business, any failure to comply with applicable federal and state documentation, coding and billing laws, rules and regulations, including the federal False Claims or similar state laws, may result in fines and other liabilities, which may adversely affect the Company’s results of operations and reputation.

The Federal False Claims Act provides for the imposition of extensive financial penalties (including treble damages and fines of over $22,000 for every false claim) if a provider submits false claims to any governmental health program either knowingly or in reckless disregard or in deliberate ignorance of the truth or falsity of the claims at issue. Liability under the False Claims Act can arise from patterns of deficient documentation, coding and billing, as well as for billing for services that are deemed not to have been medically necessary for the treatment of the patient. Many states have their own False Claims Acts as well. The Company intends to bill governmental health care programs for the TCD testing, and the False Claims Act is thus potentially applicable to the Company’s operations. Here, the Company will not be billing for the performance of the tests to governmental health care plans; the treating and ordering physician will. As a result, any patterns of uncorrected deficiencies in coding and billing for TCD tests by the physician could result in fines or other liabilities imposed on the physician. The imposition of such fines and penalties or an investigation into any alleged deficiencies by the physician could adversely affect the Company’s business, financial condition and results of operations.

Any failure to comply with all state laws relating to the Corporate Practice of Medicine or fee splitting may result in fines and other liabilities, which may adversely affect the Company’s business, financial condition and results of operations and reputation.

Many states prohibit or otherwise regulate under Corporate Practice of Medicine (“CPOM”) rules the extent to which non-licensed personnel may be involved in the practice of medicine or otherwise employ licensed personnel. Related state rules further limit the extent to which fees for professional services may be shared or “split” between parties. Under the TCD Testing line of business, such rules in some states my impact the Company’s relationship with the radiologists who will be reading and interpreting the results of the TCD tests, and thereby providing the “professional component” of such tests. In order to avoid such a potential impact, the Company is structuring its financial and billing relationships with such radiologists to be in compliance with applicable state rules by providing that the Company will not be billing for the “professional component,” which will be billed instead either by the treating and ordering physician or the radiologists themselves. Failure to comply with state CPOM and fee splitting rules, however, may result in fines and other liabilities, which may adversely affect the Company’s business, financial condition and results of operations.

Increased government involvement in healthcare could adversely affect ourthe Company’s business.

U.S. healthcare system reform under the Medicare Prescription Drug, Improvement and Modernization Act of 2003, the Patient Protection and Affordable Care Act of 2010 and other initiatives at both the federal and state level, could increase government involvement in healthcare, lower reimbursement rates and otherwise change the business environment of our customers and the other entities with which we have a business relationship. While no federal price controls are included in the Medicare Prescription Drug, Improvement and Modernization Act, any legislation that reduces physician incentives to dispense medications in their offices could adversely affect physician acceptance of our products. We cannot predict whether or when future healthcare reform initiatives at the federal or state level or other initiatives affecting our business will be proposed, enacted or implemented or what impact those initiatives may have on our business, financial condition or results of operations. Our customers and the other entities with which we have a business relationship could react to these initiatives and the uncertainty surrounding these proposals by curtailing or deferring investments, including those for our products. Additionally, government regulation could alter the clinical workflow of physicians, hospitals and other healthcare participants, thereby limiting the utility of our products and services to existing and potential customers and curtailing broad acceptance of our products and services. Additionally, new safe harbors to the federal Anti-Kickback Statute and corresponding exceptions to such law may alter the competitive landscape.

Risks Related to OurThe Company’s Common Stock

Following this offering, we will have a limited number of authorized shares of common stock available for issuance and will need to seek stockholder approval to amend our Certificate of Incorporation to either effect an increase in our authorized shares of common stock or a reverse split.

Immediately following this offering, we will have only 20,175,079 authorized but unissued shares of our common stock, of which 7,115,238 are currently reserved for issuance of outstanding options and warrants and the balance of which will be reserved for issuance of Series A Warrants. We will not have a sufficient number of authorized shares to permit exercise of the Series B Warrants. We will seek stockholder approval of an amendment to our certificate of incorporation to effect either an increase in the number of authorized shares of common stock or a reverse split, in either case, in an amount sufficient to permit the exercise in full of the Series B Warrants and fund our business. If we do not receive the requisite stockholder approval to enable us to issue equity in the future, our operations will likely be materially adversely impacted.

In addition, an increase in the authorized number of shares of common stock and the subsequent issuance of such shares could have the effect of delaying or preventing a change in control of our company without further action by our stockholders. Shares of authorized and unissued common stock could, within the limits imposed by applicable law, be issued in one or more transactions which would make a change in control of our company more difficult, and therefore less likely. Furthermore, there are risks associated with effecting a reverse stock split, including a decline in the market price of our common stock and the possibility of certain shareholders owning “odd lots” of less than 100 shares, which may be more difficult to sell, or require greater transaction costs per share to sell, than shares in “round lots” of even multiples of 100 shares. In addition, because holders of our common stock have no preemptive rights to purchase or subscribe for any unissued stock of our company, the availability of a greater number of authorized shares, whether as a result of a reverse split or an increase in the authorized number, could result in additional dilution to existing stockholders and investors in this offering.

You will be unable to exercise the Series B Warrants immediately and they may have no value under certain circumstances.

We will not have authorized shares available to permit exercise of the Series B Warrants and such warrants will not be exercisable if we do not obtain stockholder approval to either increase the number of authorized shares of common stock or effect a reverse stock split, in either case, in an amount sufficient to permit exercise in full of the Series B Warrants. If we are unable to obtain such approval, the Series B Warrants will have no value.

The Company is an “emerging growth company” and we haveit has elected to comply with certain reduced reporting and disclosure requirements which could make ourits common stock less attractive to investors.

We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, (the “JOBS Act”). For as long as we continue to be an emerging growth company, we have elected to take advantage of exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies, including (1) not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, which we refer to as the Sarbanes-Oxley Act, (2) reduced disclosure obligations regarding executive compensation in this prospectus and our periodic reports and proxy statements and (3) exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. In addition, as an emerging growth company, we are only required to provide two years of audited financial statements and two years of selected financial data in this prospectus. As a result of these reduced reporting and disclosure requirements our financial statements may not be comparable to SEC registrants not classified as emerging growth companies. We may be an emerging growth company for up to five years following the first sale of our equity securities in a public offering, although circumstances could cause us to lose that status earlier, including if the market value of our common stock held by non-affiliates exceeds $700.0 million before that time or if we have total annual gross revenue of $1.0$1.07 billion or more during any fiscal year before that time, in which cases we would no longer be an emerging growth company as of the following December 31 or, if we issue more than $1.0 billion in non-convertible debt during any three-year period before that time, we would immediately cease to be an emerging growth company. Even after we no longer qualify as an emerging growth company, we may still qualify as a “smaller reporting company” which would allow us to take advantage of many of the same exemptions from disclosure requirements, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act and reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements. We cannot predict if investors will find our common stock less attractive because we may rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.

Our independent registered public accounting firm will not be required to formally attest to the effectiveness of our internal control over financial reporting until the later of our second annual report or the first annual report required to be filed with the SEC following the date we are no longer an “emerging growth company” as defined in the JOBS Act. We cannot assure you that there will not be material weaknesses or significant deficiencies in our internal controls in the future.

Under the JOBS Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as those standards apply to private companies. We have elected to avail ourselves of this exemption from new or revised accounting standards and, therefore, will not be subject to the same new or revised accounting standards as other SEC registrants that are not emerging growth companies.

Investors may find our common stock less attractive as a result of our election to utilize these exemptions, which could result in a less active trading market for our common stock and/or the market price of our common stock may be more volatile.

OurThe Company’s directors and executive officers beneficially own a significant number of shares of ourthe Company’s common stock. Their interests may conflict with our outside stockholders, who may be unable to influence management and exercise control over ourthe business.

As of the date of this prospectus, our executive officers and directors beneficially own approximately 23.4%13% of our shares of common stock. As a result, our executive officers and directors may be able to:to affect the election or defeat the election of our directors, amend or prevent amendment to our certificates of incorporation or bylaws,Bylaws, effect or prevent a merger, sale of assets or other corporate transaction, and control the outcome of any other matter submitted to the shareholders for vote. Accordingly, our outside stockholders may be unable to influence management and exercise control over our business.

We doThe Company does not intend to pay cash dividends to ourits stockholders, so you willmay not receive any return on your investment in ourthe Company prior to selling your interest in the Company.

We have never paid any dividends to our common stockholders and do not foresee doing so as a public company. We currently intend to retain any future earnings for funding growth and, therefore, do not expect to pay any cash dividends in the foreseeable future. If we determine that we will pay cash dividends to the holders of our common stock, we cannot assure that such cash dividends will be paid on a timely basis. The success of your investment in the Company will likely depend entirely upon any future appreciation. As a result, you will not receive any return on your investment prior to selling your shares in our Company and, for the other reasons discussed in this “Risk Factors” section, you may not receive any return on your investment even when you sell your shares in our Company.

WeThe Company will require additional capital in the future to support our currentits operations, and this capital has not always been readily available.

WeAfter this offering (even if the underwriter exercises its over-allotment option), in the future, we will likely require additional debt or equity financing to fund our current operations, including, but not limited to, working capital. As a publicly-owned reporting company, we expect that it may facilitate our ability to secure additional funds. Our limited operating history makes it difficult to evaluate our current business model and future prospects. Accordingly, investors should consider our prospects in light of the costs, uncertainties, delays and difficulties frequently encountered by companies in the early stages of development, as we have, in fact, encountered. Potential investors should carefully consider the risks and uncertainties that a new company with a limited operating history and with limited funds, will face. In particular, while we do not have current plans to re-prioritize our business plan, potential investors should consider that there is a significant risk that we will not be able to:

If we raise additional funds through further issuances of equity or convertible debt securities, our existing shareholders could suffer significant dilution, and any new equity securities we issue could have rights, preferences and privileges superior to those of holders of our existing capital stock. Any debt financing secured by us in the future could involve restrictive covenants relating to our capital raising activities and other financial and operational matters, which may make it more difficult for us to obtain additional capital and to pursue business opportunities. In addition, we may not be able to obtain additional financing on terms favorable to us, if at all. If we are unable to obtain adequate financing or financing on terms satisfactory to us, when we require it, our ability to continue to support our current operations and to respond to business challenges would be significantly limited. If we cannot access the capital necessary to support our business, we would be forced to curtail our business activities or even shut down operations. If we cannot execute any one of the foregoing or similar matters relating to our business, the business may fail, in which case you would lose the entire amount of your investment in the Company.

The obligations associated with being a public company require significant resources and management attention, which may divert from ourthe Company’s business operations.

We are subject to the reporting requirements of the Securities Exchange Act, of 1934, as amended (the “Exchange Act”), and Thethe Sarbanes-Oxley Act of 2002 (“SOX”).Act. The Exchange Act requires that we file annual, quarterly and current reports with respect to our business and financial condition, proxy statement, and other information. SOXThe Sarbanes-Oxley Act requires, among other things, that we establish and maintain effective internal controls and procedures for financial reporting. Our Chief Executive Officer and Chief Accounting Officer need to certify that our disclosure controls and procedures are effective in ensuring that material information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. We will need to hire additional financial reporting, internal controls and other financial personnel in order to develop and implement appropriate internal controls and reporting procedures. As a result, we will incur significant legal, accounting and other expenses. Furthermore, the need to establish the corporate infrastructure demanded of a public company may divert management’s attention from implementing our growth strategy, which could prevent us from improving our business, results of operations and financial condition. We have made, and will continue to make, changes to our internal controls and procedures for financial reporting and accounting systems to meet our reporting obligations as a public company. However, the measures we take may not be sufficient to satisfy our obligations as a public company. In addition, we cannot predict or estimate the amount of additional costs we may incur in order to comply with these requirements. We anticipate that these costs will materially increase our selling, general and administrative expenses.

Section 404 of SOXthe Sarbanes-Oxley Act requires annual management assessments of the effectiveness of our internal control over financial reporting. In connection with the implementation of the necessary procedures and practices related to internal control over financial reporting, we may identify deficiencies. If we are unable to comply with the internal controls requirements of SOX,the Sarbanes-Oxley Act, then we may not be able to obtain the independent account certifications required by that act, which may preclude us from keeping our filings with the SEC current, and interfere with the ability of investors to trade our securities and our shares to be quoted or our ability to list our shares on any national securities exchange.

If we failthe Company fails to establish and maintain an effective system of internal controls, weit may not be able to report ourits financial results accurately or prevent fraud. Any inability to report and file ourits financial results accurately and timely could harm ourthe Company’s reputation and adversely impact the trading price of ourits common stock.

Effective internal controls are necessary for us to provide reliable financial reports and prevent fraud. If we cannot provide reliable financial reports or prevent fraud, we may not be able to manage our business as effectively as we would if an effective control environment existed, and our business and reputation with investors may be harmed. With each prospective acquisition, we will conduct whatever due diligence is necessary or prudentWe plan to assure us that the acquisition target can comply with the internal controls requirements of SOX.recruit additional personnel in order to achieve our financial reporting obligations. Notwithstanding our diligence, certain internal controls deficiencies may not be detected. As a result, any internal control deficiencies may adversely affect our financial condition, results of operations and access to capital. We have not performed an in-depth analysis to determine if historical undiscovered failures of internal controls exist, and may in the future discover areas of our internal controls that need improvement.improvement

Risks Related to OurThe Company’s Securities and this Offering

The Company’s failure to meet the continued listing requirements of Nasdaq could result in a delisting of our common stock.

On September 20, 2019, the Company received a notice (the “Notice”) from Nasdaq notifying the Company that the closing bid price of our common stock had been below $1.00 per share for 30 consecutive business days and that we no longer complied with the minimum bid price requirement for continued listing on The Nasdaq Capital Market.

The Notice has no immediate effect on the listing of our common stock on The Nasdaq Capital Market. Pursuant to Nasdaq Marketplace Rule 5810(c)(3)(A), we have been provided an initial compliance period of 180 calendar days, or until March 18, 2020, to regain compliance with the minimum bid price requirement. During the compliance period, our shares of common stock will continue to be listed and traded on The Nasdaq Capital Market. To regain compliance, the closing bid price of our common stock must meet or exceed $1.00 per share for a minimum of 10 consecutive business days during the 180 calendar day grace period.

In the event we are not in compliance with the minimum bid price requirement by March 18, 2020, we may be afforded a second 180 calendar day grace period. To qualify, we would be required to meet the continued listing requirements for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the minimum bid price requirement. In addition, we would be required to provide written notice of our intention to cure the minimum bid price deficiency during this second 180 day compliance period by effecting a reverse stock split, if necessary.

If we fail to satisfy the continued listing requirements of the NASDAQ Capital Market, including the minimum bid price requirement, Nasdaq may take steps to delist our common stock. Such a delisting would likely have a negative effect on the price of our common stock and would impair your ability to sell or purchase our common stock when you wish to do so. A delisting would adversely affect the liquidity, trading volume and likely the price of our common stock, causing the value of an investment in us to decrease and having an adverse effect on our business, financial condition and results of operations.

The Company will have broad discretion in the use of the net proceeds from this offering and may fail to apply these proceeds effectively.

The Company’s management will have broad discretion in the application of the net proceeds of this offering, including using the proceeds to conduct operations, expand and implement the Company’s business lines and for general working capital. The Company may also use the net proceeds of this offering to acquire or invest in complementary businesses, products, or technologies, or to obtain the right to use such complementary technologies. We have no commitments with respect to any acquisition or investment, however we do seek opportunities and transactions that management believes will be advantageous to the Company and its operations or prospects. We cannot specify with certainty the actual uses of the net proceeds of this offering. You may not agree with the manner in which our management chooses to allocate and spend the net proceeds. Pending their use, we may invest the net proceeds from this offering in a manner that does not produce income or that loses value. The failure by our management to apply these funds effectively could harm our business, financial condition and results of operations.

The Company’s stock price may be volatile, and you may not be able to resell your shares at or above the purchase price.

The market price of our common stock is volatile and could fluctuate widely in price in response to various factors, many of which are beyond our control, including the following:

In addition, the securities markets have from time to time experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies. These market fluctuations may also materially and adversely affect the market price of our common stock.

Our share price may decline due to the large number of shares recently eligible for sale.

The market price of our common stock could decline as a result of sales of a large number of shares of common stock in the market after the recent expiration of certain lock-up restrictions imposed on our shareholders in connection with our initial public offering, or the perception that such sales could occur. All of our executive officers, directors and holders of substantially all of our outstanding capital stock were subjected to lock-up agreements that restrict their ability to transfer shares of our capital stock for 180 days from the date of the underwriting agreement that was executed in connection with our initial public offering. Such lock-up restrictions expired on September 26, 2019. In connection with this offering, our directors, officers and certain stockholders will be subject to additional lock-up restrictions for a period of 180 days following this offering. Future sales, or the possibility that these sales may occur, also might make it more difficult for us to sell equity securities in the future at a time and at a price that we deem appropriate.

There is no public market for the Pre-Funded Warrants or the Warrants being offered in this offering.

There is no established public trading market for the Pre-Funded Warrants or the Warrants being offered in this offering, and we do not expect a market to develop. In addition, we do not intend to apply to list the Pre-Funded Warrants or the Warrants on any securities exchange or nationally recognized trading system, including Nasdaq. Without an active market, the liquidity of the Pre-Funded Warrants and the Warrants will be limited.

The Warrants are speculative in nature.

The Warrants offered hereby do not confer any rights of common stock ownership on their holders, such as voting rights or the right to receive dividends, but rather merely represent the right to acquire shares of common stock at a fixed price. Specifically, commencing on the date of issuance, holders of the Warrants may exercise their right to acquire the common stock and pay an exercise price of $           (based on the public offering price of $          per share of common stock), or     % of the public offering price of the common stock. Moreover, following this offering, the market value of the Warrants is uncertain and there can be no assurance that the market value of the Warrants will equal or exceed their public offering price. Furthermore, each Warrant will expire five years from the original issuance date.

In the event our common stock price does not exceed the exercise price of the Warrants during the period when the Warrants are exercisable,the Warrants may not have any value.

Holders of Pre-Funded Warrants or Warrants purchased in this offering will have no rights as common stockholders until such holders exercise such warrants and acquire our common stock.

Until holders of Pre-Funded Warrants or Warrants acquire shares of our common stock upon exercise thereof, holders of such warrants will have no rights with respect to the shares of our common stock underlying such warrants. Upon exercise of the Pre-Funded Warrants or Warrants, such holders will be entitled to exercise the rights of a common stockholder only as to matters for which the record date occurs after the exercise date.

Exercise of ouroutstanding options and warrants which may cause significant dilution to our shareholders.

We have a number of outstanding options and warrants, including outstanding August Warrants. We will also be issuing Warrants to purchase an aggregate of 19,342,359 shares of common stock in this offering. The August Warrants to purchase 226,200 shares of common stock are currently exercisable. These options and warrants provide the right to purchase additional shares of common stock at a price that may be less than the then prevailing market price per share of common stock, which therefore may cause additional dilution to our shareholders.

If we are deemed a “penny stock” issuer, you may have difficulty selling shares of our common stock.

The Company’s common stock is subject to the provisions of Section 15(g) and Rule 15g-9 of the Exchange Act, commonly referred to as the “penny stock rules.” Section 15(g) sets forth certain requirements for transactions in penny stock, and Rule 15g-9(d) incorporates the definition of “penny stock” that is found in Rule 3a51-1 of the Exchange Act. The SEC generally defines a penny stock to be any equity security that has a market price less than $5.00 per share (other than securities registered on certain national securities exchanges or quoted on the NASDAQ Stock Market), subject to certain exceptions. There can be no assurance that our shares of common stock will continue to qualify for exemption from the penny stock rules.

Public company compliance may make it more difficult to attract and retain officers and directors.

SOXThe Sarbanes Oxley Act and rules implemented by the SEC have required changes in corporate governance practices of public companies. As a public company, these rules and regulations increase our compliance costs and make certain activities more time consuming and costly. As a public company, these rules and regulations may make it more difficult and expensive for us to maintain our director and officer liability insurance and we may be required to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. As a result, it may be more difficult for us to attract and retain qualified persons to serve on our Board of Directors or as executive officers, and to maintain insurance at reasonable rates, or at all.

Our stock price may be volatile and you may not be able to resell your shares at or above the purchase price.

The market price of our common stock is likely to be highly volatile and could fluctuate widely in price in response to various factors, many of which are beyond our control, including the following:

In addition, the securities markets have from time to time experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies. These market fluctuations may also materially and adversely affect the market price of our common stock.

Our shares of common stock are not publicly traded and there can be no assurance that there will be an active market for our shares of common stock in the future.

Our shares of common stock are not currently publicly traded and timing for the commencement of trading is uncertain. There can be no assurance that there will be an active market for our shares of common stock in the future. If we are able to establish a public market for our securities, the market liquidity will be dependent on the perception of our operating business, among other things.  We intend to take certain steps including utilizing investor awareness campaigns and firms, press releases, road shows and conferences to increase awareness of our business. Any steps that we might take to bring us to the awareness of investors may require that we compensate consultants with cash and/or stock. There can be no assurance that there will be any awareness generated or the results of any efforts will result in any impact on our trading volume. Consequently, investors may not be able to liquidate their investment or liquidate it at a price that reflects the value of the business, and trading may be at an inflated price relative to the performance of the Company due to, among other things, the availability of sellers of our shares.

If an active market should develop, the price may be highly volatile. If there is a low price for our shares of common stock, many brokerage firms or clearing firms may not be willing to effect transactions in the securities or accept our shares for deposit in an account.  Many lending institutions will not permit the use of low priced shares of common stock as collateral for any loans.

We are subject to penny stock regulations and restrictions and you may have difficulty selling shares of our common stock.

Our common stock will be subject to the provisions of Section 15(g) and Rule 15g-9 of the Exchange Act, commonly referred to as the “penny stock rules.”  Section 15(g) sets forth certain requirements for transactions in penny stock, and Rule 15g-9(d) incorporates the definition of “penny stock” that is found in Rule 3a51-1 of the Exchange Act.  The SEC generally defines a penny stock to be any equity security that has a market price less than $5.00 per share, subject to certain exceptions. We will be subject to the SEC’s penny stock rules.

Since our common stock will be deemed to be penny stock, trading in the shares of our common stock will be subject to additional sales practice requirements on broker-dealers who sell penny stock to persons other than established customers and accredited investors. “Accredited investors” are persons with assets in excess of $1,000,000 (excluding the value of such person’s primary residence) or annual income exceeding $200,000 or $300,000 together with their spouse. For transactions covered by these rules, broker-dealers must make a special suitability determination for the purchase of such security and must have the purchaser’s written consent to the transaction prior to the purchase. Additionally, for any transaction involving a penny stock, unless exempt from the rules require the delivery, prior to the first transaction of a risk disclosure document, prepared by the SEC, relating to the penny stock market.  A broker-dealer also must disclose the commissions payable to both the broker-dealer and the registered representative and current quotations for the securities.  Finally, monthly statements must be sent disclosing recent price information for the penny stocks held in an account and information to the limited market in penny stocks. Consequently, these rules may restrict the ability of broker-dealer to trade and/or maintain a market in our common stock and may affect the ability of the Company’s stockholders to sell their shares of common stock.

There can be no assurance that our shares of common stock will qualify for exemption from the penny stock rules. In any event, even if our common stock was exempt from the penny stock rules, we would remain subject to Section 15(b)(6) of the Exchange Act, which gives the SEC the authority to restrict any person from participating in a distribution of penny stock if the SEC finds that such a restriction would be in the public interest.

Forward Looking Statements

This prospectus contains forward-looking statements. These forward-looking statements relate to future eventscontain information about our expectations, beliefs or future predictions, including eventsintentions regarding our product development and commercialization efforts, business, financial condition, results of operations, strategies or predictions relating to our future financial performance,prospects, and other similar matters. These forward-looking statements are based on management’s current expectations estimates, forecasts and projectionsassumptions about us, our future performance, our beliefsevents, which are inherently subject to uncertainties, risks and management’s assumptions.  Theychanges in circumstances that are generally identifiabledifficult to predict. These statements may be identified by use of the words “may,”such as “may”, “should”, “could”, “predict”, “potential”, “believe”, “will” “should,” “expect,” “plan,” “anticipate,” “believe,” “feel,” “confident,” “estimate,” “intend,” “predict,” “forecast,” “project,” “potential” or likely result”, “expect”, “continue”, “will”, “anticipate”, “seek”, “estimate”, “intend”, “plan”, “projection”, “would” and “outlook”, or the negative version of such termsthose words or phrases or other variationscomparable words or phrases of a future or forward-looking nature.

Actual results could differ materially from those contained in forward-looking statements. Many factors could cause actual results to differ materially from those in forward-looking statements, including those matters discussed below, as well as those listed in the section titled “Risk Factors” above.

Other unknown or unpredictable factors that could also adversely affect our business, financial condition and results of operations may arise from time to time. Given these risks and uncertainties, the forward-looking statements discussed in this prospectus may not prove to be accurate. Accordingly, you should not place undue reliance on these words or comparable terminology.  Theseforward-looking statements, arewhich only predictions and involve known and unknown risks, uncertainties and other factors, includingreflect the risks described under “Risk Factors” that may causeviews of the Company’s management as of the date of this prospectus. We undertake no obligation to update or its industry’srevise forward-looking statements to reflect changed assumptions, the occurrence of unanticipated events or changes to future operating results or expectations, except as required by law.

You should read this prospectus and the documents that we reference in this prospectus and have filed as exhibits to the registration statement of which this prospectus forms a part completely and with the understanding that our actual future results levels of activity, performance or achievements tomay be materially different from any future results, levelswhat we expect. We qualify all of activity, performance or achievements expressed or implied by such forward-looking statements.  In addition to the risks described in Risk Factors, important factors to consider and evaluate in suchour forward-looking statements include: (i) general economic conditions and changes in the external competitive market factors which might impact the Company’s results of operations; (ii) unanticipated working capital or other cash requirements including those created by the failure of the Company to adequately anticipate the costs associated with acquisitions and other critical activities; (iii) changes in the Company’s corporate strategy or an inability to execute its strategy due to unanticipated changes; and (iv) the failure of the Company to complete any or all of the transactions described herein on the terms currently contemplated.  In light of these risks and uncertainties, many of which are described in greater detail elsewhere in this Risk Factors discussion, there can be no assurance that the forward-lookingcautionary statements contained in this prospectus willsection and elsewhere in fact transpire.this prospectus.

Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee future results, levels of activity, performance or achievements.  We will update or revise the forward-looking statements to the extent required by applicable law.

USE OF PROCEEDS

We will not receive any of

The Company estimates that the net proceeds from the issuance and sale of shares of common stock, Warrants and Pre-Funded Warrants in this offering will be approximately $8,670,000 after deducting the underwriting discounts and commissions and estimated offering expenses payable by the Selling Securityholders.However, weCompany and assuming no issuance of any Pre-Funded Warrants, no exercise of the over-allotment option and a public offering price of $0.517 per share of common stock, which is the last reported sale price of our common stock on Nasdaq on October 23, 2019, and excluding the proceeds, if any, from the exercise of any Warrants issued in this offering. We will only receive additional proceeds from the exercise of the warrantsWarrants issuable in this offering if theysuch warrants are exercised at their exercise price of $         per share of common stock and the holders of such Warrants pay the exercise price in cash.

The Company intends to use the net proceeds from this offering to conduct operations, increase marketing efforts, increase investment in the Company’s existing business initiatives and products, developing the new NutriGuard brand and related product line, a focused, on-going review of potential acquisition opportunities and for cash bygeneral working capital.

The Company may also use a portion of the Selling Securityholders, and willnet proceeds of this offering to invest in or acquire complementary businesses, products, or technologies, or to obtain the right to use such proceeds for working capital purposes.complementary technologies. The Company has no commitments with respect to any acquisition or investment and is not currently involved in any negotiations with respect to any such transactions.

MARKET FOR REGISTRANT’S COMMON EQUITY AND RELATED STOCKHOLDER MATTERSAs of the date of this prospectus, the Company cannot specify with certainty all of the particular uses for the net proceeds to be received upon the completion of this offering. The amounts and timing of its actual expenditures will depend on numerous factors, including the status of its product development efforts, sales and marketing activities, technological advances, amount of cash generated or used by its operations and competition. Accordingly, the Company’s management will have broad discretion in the application of the net proceeds and investors will be relying on the judgment of its management regarding the application of the proceeds of this offering.

There is currently no public market for our shares of common stock.DIVIDEND POLICY

We intend to seek a listing of our common stock on the NYSE American under the symbol “GHSI” or “GRD” if available, however, we cannot assure you that our listing will be approved or that a public trading market will ever develop.

Dividend Policy

Guardion Health Sciences, Inc.The Company has not declared nor paid any cash dividend on ourits common stock, and weit currently intendintends to retain future earnings, if any, to finance the expansion of ourits business, and we dothe Company does not expect to pay any cash dividends in the foreseeable future. The decision whether to pay cash dividends on ourthe common stock will be made by ourits board of directors, in their discretion, and will depend on ourthe Company’s financial condition, results of operations, capital requirements and other factors that ourits board of directors considers significant.

UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION

Acquisition of VectorVision, Inc.

On September 29, 2017, Guardion Health Sciences, Inc. (the “Company”) completed the acquisition of VectorVision Ohio, whereby we acquired substantially all the assets and assumed certain liabilities of VectorVision in exchange for 3,050,000 shares of our common stock, pursuant to an Asset Purchase and Reorganization Agreement. The shares issued to VectorVision Ohio stockholders represented approximately 11% of the Company’s issued and outstanding common stock immediately following the transaction. The Company acquired substantially all VectorVision Ohio assets, including inventory, equipment, trademarks and copyrights, and assumed certain outstanding line of credit and accounts payable liabilities.

We will account for the VectorVision acquisition using the acquisition method of accounting for business combinations under GAAP. Under the acquisition method of accounting, the total consideration paid is allocated to an acquired company’s tangible and intangible assets, liabilities, and any non-controlling interest based on their estimated fair values as of the acquisition date. Once we complete our final valuation processes for the VectorVision acquisition, we may report changes to the value of the assets acquired, as well as the amount of goodwill, and those changes could differ materially from what we present here.

The following unaudited pro forma condensed combined financial statements are based on our historical financial statements and VectorVision’s historical financial statements as adjusted to give effect to pro forma events that are (1) directly attributable to the acquisition, (2) factually supportable and (3) with respect to the pro forma condensed combined statements of operations, expected to have a continuing impact on the combined results following the acquisition. The unaudited pro forma condensed combined statements of operations for the nine months ended September 30, 2017 and the 12 months ended December 31, 2016 give effect to these transactions as if they had occurred on January 1, 2016. A pro forma balance sheet for the period ended September 30, 2017 is not being furnished herein because the balance sheet of VectorVision, Inc. as of September 30, 2017 is consolidated with the Company’s balance sheet as of September 30, 2017 that is included in the Company’s Quarterly Report on Form 10-Q for the quarter period ended September 30, 2017, which was filed with the SEC on November 13, 2017.

The pro forma condensed combined financial statements do not necessarily reflect what the combined company’s financial condition or results of operations would have been had the acquisition occurred on the dates indicated. They also may not be useful in predicting the future financial condition and results of operations of the combined company. The actual financial position and results of operations may differ significantly from the pro forma amounts reflected herein. The pro forma condensed combined financial statements should be read together with the Company’s and VectorVision’s historical financial statements included herein.

Guardion Health Sciences, Inc.

Unaudited Pro Forma Condensed Combined Statement of Operations

For the Nine Months Ended September 30, 2017