Lumova has developed eMox, a medical device powered by AI technology, that is the only device that can provide an objective and automatic assessment for visual acuity and amblyopia in clinics.
Lumova has developed a unique medical instrument eMox, with proprietary technologies including AI algorithms for pattern recognition, for the early detection and monitoring of neurological eye diseases including amblyopia.
Amblyopia is reduced vision in one or both eyes caused by visual deprivation in childhood. Unless it is successfully treated in early childhood, amblyopia usually persists into adulthood, and is the most common cause of monocular visual impairment, which may also affect children’s learning and social development.
Presently, there is no clinical use product for young children visual acuity and amblyopia assessment and monitoring. The devices used by clinicians today, photoscreen and autorefractor, are only for assessing risk factors rather than amblyopia.
The user-friendly device, eMox is the only device that can provide an objective and automatic assessment for visual acuity and amblyopia in clinical environment.
Using a direct-sales strategy, Lumova will sell eMox to eye-care professionals and pediatricians. The potential market size in the US is $2.3B
Bank balance as of December 16, 2019: $3,000.00
In the following, the terms of “we” and the “Company” are referred to Lumova Corporation.
An investment in the shares we are offering for sale involves a substantial degree of risk and should be undertaken only by persons who can afford an investment involving such risks.An investment in our shares is suitable only for persons who are interested in a long-term investment and can afford to lose their entire investment.Persons interested in purchasing our shares should carefully consider, among others, the following risks:
Lack of Operating History
The Company has a limited operating history upon which an evaluation of the Company can be based, and its prospects are subject to the risks, expenses and uncertainties frequently encountered by companies with new products.There can be no assurance that the Company will be successful in addressing such risks and the failure of the Company to do so could have a material adverse effect on the Company’s business, results of operations and financial condition.
As of December 2019, the Company has no accumulated deficit. There can be no assurance that the Company will have any revenue in the future.The Company has not achieved profitability on a quarterly or annual basis to date, and the Company anticipates that it will continue to incur losses through the commercialization period.The Company currently expects to increase its operating expenses, expand its sales and marketing operations and continue to develop and extend its products.To the extent that such expenses precede or are not subsequently followed by increased revenues, the Company’s business, results of operations and financial condition could be materially and adversely affected.
The limited operating history of the Company and the uncertain nature of the markets addressed by the Company make the prediction of future results of operations difficult and, therefore, the revenue experienced by the Company should not be taken as indicative of the rate of revenue, if any, that can be expected in the future.The Company believes that period-to-period comparisons of its results of operations are not meaningful and that the results for any period should not be relied upon as an indication of future performance.
Determination of Offering Price
The offering price was determined based on market analysis and Lumova’s operating history.There can be no assurance that the price quotation, if any, that an investor may obtain for the sale of their shares after this offering will be at or above purchase price per share.
Dependence on Key Personnel
The Company’s performance is substantially dependent on the performance of its senior management and key personnel.In particular, the Company’s success depends substantially on the continued efforts of current management.The Company has not acquired key person life insurance.The loss of the services for any reason of any of its executive officers or other key employees could have a material adverse effect on the business, results of operations and financial condition of the Company.
Many of the Company’s current and potential competitors have longer operating histories, larger customer bases and significantly greater financial, marketing and other resources than the Company.These competitors are able to respond more quickly to new or emerging products and changes in customer requirements, and to devote greater resources to the development, promotion and sale of their products and services than the Company.These competitors may also be able to charge lower prices for their products than the Company because of their greater resources.There can be no assurance that the Company will be able to compete successfully against its current or future competitors.
Limited Public Trading Market
We do not currently intend to apply to any securities exchange, including the NASDAQ stock market, to have our shares listed for trading.A public market having depth, liquidity and orderliness depends on the presence in the marketplace of a sufficient number of buyers and sellers at any given time.Due to the relatively small size of the offering and expected concentration of ownership, it is unlikely that an active or liquid trading market in the shares will develop in the near term, and if such a market develops, there is no assurance that it will continue.In an inactive and/or illiquid market, shareholders wishing to sell their shares may have to find buyers through their own efforts.In addition, a sale of a large amount of shares could adversely affect the prevailing market price.
Risk of Loss of Principal
The shares of common stock being offered by this offering are not insured or guaranteed by the FDIC or any other governmental agency.The shares involve an investment risk, including a risk of loss of your entire investment.You should only invest in this offering if you can bear the risk of the loss of your entire investment.
Need to Raise Additional Capital
We believe that if we sell the minimum number of shares offered in this offering, we will have adequate capital to sustain our operations for twelve months.We may need to seek additional funding through the offer and sale of our shares of common stock in order to continue our operations.Sale of additional shares of our common stock will dilute your interests.If it becomes necessary to raise additional capital, there can be no assurance that we will be able to obtain additional financing or that such financing can be obtained on terms favorable to us.We may have to sell additional shares below the offering price in this offering.Furthermore, if it becomes necessary to raise additional capital in the future to support our growth, an offering of additional shares would dilute the ownership percentage of purchasers of shares in this offering and, depending on the subscription price of the additional shares, could be dilutive to book value per share of then-existing shareholders. In any additional offerings, you do not have the right to purchase any additional shares, it is the discretion of the Board whether or not to offer you the ability to purchase more shares and the number of shares you may buy.
If we fail to obtain FDA approval to market eMox, we will be adversely affected.
We will not be able to market eMox in the U.S. unless and until we receive FDA approval. Even if we obtain regulatory approval for our medical device, that approval may be subject to limitations on the indicated uses for which it may be marketed. Even after granting regulatory approval, the FDA and regulatory agencies in other countries continue to review and inspect marketed products, manufacturers and manufacturing facilities, which may create additional regulatory burdens. Later discovery of previously unknown problems with a product, manufacturer or facility, may result in restrictions on the product or manufacturer, including a withdrawal of the product from the market. Further, regulatory agencies may establish additional regulations that could prevent or delay regulatory approval of our products.
In addition, future governmental action or changes in FDA policies or precedents may result in delays or rejection of an application for marketing authorization. The FDA has considerable discretion in determining whether to grant marketing authorization for a medical device and may delay or deny authorization even in circumstances where the applicant’s clinical trials have proceeded in compliance with FDA procedures and regulations and have met the established end points of the trials. Despite all of our efforts, the FDA could refuse to grant marketing authorization for eMox for any indication.
Challenges to FDA determinations are generally time consuming and costly, and rarely succeed. We can give no assurance that we will obtain FDA marketing authorization for eMox for any indication. The failure to obtain any authorization would have severe adverse consequences.
If we fail to obtain regulatory approvals in foreign jurisdictions, we will not be able to market eMox abroad.
We intend to seek marketing authorization to market eMox in other international markets, including European Union countries and China. Whether or not FDA marketing authorization has been obtained, we must obtain separate regulatory authorizations in order to market our products in the European Union and many other foreign jurisdictions. The regulatory processes differ among these jurisdictions, and the time needed to secure marketing authorization may be even longer than that required for FDA authorization. Marketing authorization in any one jurisdiction does not ensure authorization in a different jurisdiction. As a result, obtaining foreign authorizations will require additional expenditures and significant amounts of time. We can give no assurance that we will obtain marketing authorization for eMox in any foreign jurisdiction.
Clinical trials are extremely costly and subject to numerous risks and uncertainties.
To gain authorization from the FDA and European and Asian regulatory authorities for the commercial sale of any product, including eMox, we may need to demonstrate in clinical trials, and thereby satisfy the regulatory authorities as to, the safety and efficacy of the product. Also, to establish a baseline result of tests and a threshold for referral, we need clinical trials. Clinical trials are expensive and time-consuming. Clinical trials are also subject to numerous risks and uncertainties not within our control. For example, data we obtain from preclinical and clinical studies are susceptible to varying interpretations that can impede regulatory approval.
In addition, many factors could delay or result in termination of ongoing or future clinical trials. Results from ongoing or completed preclinical or clinical studies or analyses could raise concerns, real or perceived, over the safety or efficacy of an investigational medical device. We cannot assure investors that the FDA will not delay the development of eMox by further continuing its current hold or placing other clinical trials we sponsor or others may sponsor on hold in the future. A clinical trial may also be delayed by slow patient enrollment. There may be limited availability of patients who meet the criteria for certain clinical trials. Delays in planned patient enrollment can result in increased development costs and delays in regulatory approvals. Further, we rely on investigating physicians and the hospital and ophthalmic and pediatric office trial sites to enroll patients. In addition, patients may experience adverse medical events or side effects resulting in delays, whether or not the events or the side effects relate to our product.
We must successfully complete our clinical trials to be able to market our product.
To be able to market the medical device in the U.S. and across the EU and Asia, we must demonstrate, through extensive preclinical studies and clinical trials, the safety and efficacy of our processes and product candidates. If our clinical trials are not successful, our products may not be marketable.
Our ability to complete our clinical trials in a timely manner depends on many factors, including the rate of patient enrollment. Patient enrollment can vary with the size of the patient population, the proximity of suitable patients to clinical sites, perceptions of the utility of our medical device and the eligibility criteria for the study. If we experience delays in patient accrual, we could experience increased costs and delays associated with clinical trials, which would impair our product development programs and our ability to market our products. Furthermore, the FDA monitors the progress of clinical trials and it may suspend or terminate clinical trials at any time due to patient safety or other considerations.
Even if successful clinical results are reported for a product from a completed clinical trial, this does not mean that the results will be sustained over time, or will be sufficient for a marketable or regulatory approvable product.
We may not be able to raise the required capital to conduct our operations and develop and commercialize our products.
We will require additional capital resources after the current fund raise in order to conduct our operations including production, sales, marketing and product further improvement.
Our future capital requirements will depend upon many factors, including:
Because of our long-term funding requirements, we intend to try to access the private equity markets if conditions are favorable to complete a financing, even if we do not have an immediate need for additional capital at that time, or whenever we require additional operating capital. This additional funding may not be available to us on reasonable terms, or at all. If adequate funds are not available in the future, we may be required to further delay or terminate research and development programs, curtail capital expenditures, and reduce business development and other operating activities.
Our inability to complete our product development activities successfully would severely limit our ability to operate or finance operations.
In order to commercialize our medical device in the U.S. the EU and the Asia, we must complete substantial clinical trials, and obtain sufficient safety and efficacy results to support required registration approval and market acceptance of our medical device. We may not be able to successfully complete the development of our product, or successfully market our technologies or product. We, and any of our potential collaborators, may encounter problems and delays relating to research and development, regulatory approval and intellectual property rights of our technologies and product. Our research and development programs may not be successful. Our technologies and product may not prove to be safe and efficacious in clinical trials, and we may not obtain the requisite regulatory approvals for our technologies or product. If any of these events occur, we may not have adequate resources to continue operations for the period required to resolve the issue delaying commercialization and we may not be able to raise capital to finance our continued operation during the period required for resolution of that issue.
If our patents and proprietary rights do not provide substantial protection, then our business and competitive position will suffer.
Our success depends in large part on our ability to develop or license and protect proprietary products and technologies. The scope of any of our issued patents may not be sufficiently broad to offer meaningful protection. In addition, even the patents are approved they could be successfully challenged, invalidated or circumvented so that our patent rights would not create an effective competitive barrier. We also rely on trade secrets and unpatentable know-how that we seek to protect, in part, by confidentiality agreements with our employees, consultants, suppliers and licensees. These agreements may be breached, and we might not have adequate remedies for any breach. If this were to occur, our business and competitive position would suffer.
Potential product liability claims could affect our earnings and financial condition.
We face an inherent business risk of exposure to product liability claims in the event that the manufacture and/or use of our medical device during clinical trials, or after commercialization, results in adverse events. As a result, we may incur significant product liability exposure, which could exceed existing insurance coverage. We may not be able to maintain adequate levels of insurance at reasonable cost and/or reasonable terms. Excessive insurance costs or uninsured claims would increase our operating loss and affect our financial condition.
FORWARD LOOKING STATEMENTS
THIS DOCUMENT CONTAINS “FORWARD-LOOKING STATEMENTS” CONCERNING THE COMPANY AND ITS OPERATIONS, PERFORMANCE, FINANCIAL CONDITION AND PROSPECTS, ALL OF WHICH INVOLVES RISKS AND UNCERTAINTY.OUR ACTUAL RESULTS COULD DIFFER MATERIALLY FROM THOSE ANTICIPATED IN THESE FORWARD-LOOKING STATEMENTS AS A RESULT OF MANY FACTORS, INCLUDING THOSE DESCRIBED UNDER THE HEADING “RISK FACTORS” AND CONTAINED ELSEWHERE IN THIS DOCUMENT.STATEMENTS THAT CONTAIN “MAY,” “WOULD,” “COULD,” “WILL,” “EXPECT,” “ANTICIPATE,” “BELIEVE,” “INTEND,” “PLAN,” AND “ESTIMATE,” AS WELL AS SIMILAR PREDICTIVE STATEMENTS, ARE SUCH FORWARD-LOOKING STATEMENTS.
INVESTMENT IN THE SHARES INVOLVES A SUBSTANTIAL DEGREE OF RISK AND SHOULD BE CONSIDERED ONLY AS A LONG-TERM INVESTMENT.AN ACTIVE OR LIQUID TRADING MARKET FOR OUR COMMON STOCK WILL NOT LIKELY DEVELOP IN THE NEAR TERM.SEE “RISK FACTORS” ABOVE.
WE ARE OFFERING THE SHARES PURSUANT TO AN EXEMPTION FROM THE SECURITIES ACT OF 1933, AS AMENDED.THIS OFFERING HAS NOT BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION.THE MERITS OF THE SHARES HAVE NOT BEEN PASSED UPON BY THE SECURITIES AND EXCHANGE COMMISSION, THE NEW JERSEY BUREAU OF SECURITIES, OR ANY OTHER GOVERNMENTAL AGENCY, NOR HAVE SUCH ENTITIES PASSED UPON THE ACCURACY OR ADEQUACY OF THIS DOCUMENT.THIS DOCUMENT DOES NOT CONSTITUTE AN OFFER TO SELL, OR A SOLICITATION OF AN OFFER TO BUY, ANY OF THE SHARES OFFERED HEREBY IN ANY JURISDICTION TO ANY PERSON TO WHOM IT IS UNLAWFUL TO MAKE SUCH OFFER OR SOLICITATION IN SUCH JURISDICTION.
NO AGENT OR OFFICER OF THE COMPANY OR ANY OTHER PERSON HAS BEEN AUTHORIZED TO GIVE ANY INFORMATION OR TO MAKE ANY REPRESENTATIONS OTHER THAN THOSE CONTAINED IN THIS DOCUMENT, AND, IF GIVEN OR MADE, SUCH INFORMATION AND REPRESENTATIONS SHOULD NOT BE RELIED UPON AS HAVING BEEN AUTHORIZED BY US.