836429--10/28/2009--SYNERGETICS_USA

related topics

{product, liability, claim}

{product, market, service}

{regulation, government, change}

{product, candidate, development}

{customer, product, revenue}

{stock, price, operating}

{personnel, key, retain}

{operation, international, foreign}

{operation, natural, condition}

{property, intellectual, protect}

{provision, law, control}

{system, service, information}

{loan, real, estate}

{condition, economic, financial}

If any of our single source suppliers were to cease providing components, we may not be able to produce our products. The medical device industry is highly competitive, and we may be unable to compete effectively with other companies. Our future results are dependent, in part, upon the successful transition of our neurosurgical products to our marketing partners. Our industry is experiencing greater scrutiny and regulation by governmental authorities, which may lead to greater governmental regulation in the future. A significant part of our neurosurgical products sales comes from a single customer, which makes us vulnerable to the loss of that customer. Our products may not be accepted in the market. If we do not introduce new commercially successful products in a timely manner, our products may become obsolete over time, thereby decreasing our revenue and profitability. Quality problems with our processes, goods and services could harm our reputation for producing high quality products and erode our competitive advantage. Our operating results may fluctuate. Changes in the health care industry may require us to decrease the selling price for our products or could result in a reduction in the size of the market for our products, each of which could have a negative impact on our financial performance. Delays in the receipt or failure to receive clearances or approvals, the loss of previously received clearances or approvals, or failure to comply with existing or future regulatory requirements could have a material adverse effect on our business, financial condition, results of operations and future growth prospects. We may be subject to penalties and may be precluded from marketing our products if we fail to comply with extensive governmental regulations. We may be unable to maintain our ISO certification or CE mark which allows us to sell our products in the European medical market. We will first need to obtain electrical safety approval to market our applicable products under development. Our intellectual property rights may not provide meaningful commercial protection for our products, which could adversely affect our ability to compete in the market. We may have product liability claims, and our insurance may not cover all claims. The loss of key personnel could harm our business. If we are unable to hire, train and retain additional sales, marketing, manufacturing, engineering and finance personnel, our growth could be impaired. We plan to expand our international sales and distribution operations, and the success of our international expansion is subject to significant uncertainties. We have international suppliers of various products. Our cash is maintained with a regional bank which given the current financial crisis may not be fully insured. The market price of our stock may be highly volatile. Synergetics USA has anti-takeover defenses that could delay or prevent an acquisition and could adversely affect the price of its common stock. Material increases in interest rates could potentially be a detriment to sales. Because we do not require training for users of our products, there exists an increased potential for misuse of our products, which could harm our reputation and our business. If our facilities were to experience catastrophic loss, our operations would be seriously harmed.

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836429--10/28/2009--SYNERGETICS_USA_INC