1424768--3/31/2010--VYCOR_MEDICAL

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{customer, product, revenue}

{control, financial, internal}

{interest, director, officer}

{product, market, service}

{cost, operation, labor}

{acquisition, growth, future}

{stock, price, operating}

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{personnel, key, retain}

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{regulation, government, change}

{loss, insurance, financial}

Risks Related to Our Financials We are a recently formed company that has not achieved profitable operations. If our business plan fails, you may lose your entire investment. We were formed on June 17, 2005 and have a limited operating history and, accordingly, you will not have any basis on which to evaluate our ability to achieve our business objectives. The absence of any significant operating history for us makes forecasting our revenue and expenses difficult, and we may be unable to adjust our spending in a timely manner to compensate for unexpected revenue shortfalls or unexpected expenses. Our limited operating history does not afford investors a sufficient history on which to base an investment decision Our independent auditors have expressed substantial doubt about our ability to continue as a going concern, which may hinder our ability to continue as a going concern and our ability to obtain future financing. Our revenue will be dependent upon acceptance of our products by the market. The failure of such acceptance will cause us to curtail or cease operations. Risks Related to Our Business We cannot be certain that we will obtain patents for our devices or that such patents will protect us from competitors We are dependent on two key vendors to manufacture our products. We rely on independent distributors to assist in the sale and marketing of our products We will need to raise substantial additional funds to reach viability and continue operations We may not be successful in capturing desired market share if products are not compatible with navigational systems. Our development of new products may be more expensive than anticipated and that we may not have sufficient resources to realize our business plan. Sales may not produce profits. Our products may not be accepted in the marketplace. Even if our products are approved by regulatory authorities, if we or our suppliers fail to comply with ongoing regulatory requirements, or if we experience unanticipated problems with our products, these products could be subject to restrictions or withdrawal from the market Because product liability is inherent in the medical devices industry and insurance is expensive and difficult to obtain, we may be exposed to large lawsuits. Because the healthcare industry is subject to changing policies and procedures, we may find it difficult to continue to compete in an uncertain environment The market success of our product candidates will be dependent in part upon third-party reimbursement policies that are often subject to change Some of our competitors are more established and better capitalized than we are and we may be unable to establish market share. We will need to increase the size of our organization, and may experience difficulties in managing growth. We are subject to compliance with securities law, which exposes us to potential liabilities, including potential rescission rights The availability of a large number of authorized but unissued shares of common stock may, upon their issuance, lead to dilution of existing stockholders We may need additional capital that could dilute the ownership interest of investors We rely on Mr. Kenneth T. Coviello, our Chief Executive Officer and Ms. Heather Vinas, our President, for the management of our business, and the loss of their services may significantly harm our business and prospects. We may not be able to hire and retain qualified personnel to support our growth and if we are unable to retain or hire such personnel in the future, our ability to improve our products and implement our business objectives could be adversely affected. We may not have adequate internal accounting controls. While we have certain internal procedures in our budgeting, forecasting and in the management and allocation of funds, our internal controls may not be adequate. We have inadequate insurance coverage Risks Related to an Investment in Our Common Stock Fountainhead Capital Management Limited effectively controls us through their position and stock ownership and their interests may differ from other stockholders We do not intend to pay cash dividends in the foreseeable future Our common stock is subject to the Penny Stock Regulations Our common stock may be illiquid and subject to price volatility unrelated to our operations Our securities are not registered pursuant to Section 12 of the Securities Exchange Act of 1934, as amended

Full 10-K form ▸

1424768--3/31/2010--VYCOR_MEDICAL_INC