1142596--2/26/2010--NUVASIVE

related topics

{product, liability, claim}

{acquisition, growth, future}

{product, market, service}

{product, candidate, development}

{property, intellectual, protect}

{stock, price, operating}

{stock, price, share}

{condition, economic, financial}

{customer, product, revenue}

Pricing pressure from our competitors may impact our ability to sell our products at prices necessary to expand our operations and increase profitability. We are in a highly competitive market segment and face competition from large, well-established medical device manufacturers as well as new market entrants. Our future success depends on our strategy of obsoleting our own products and our ability to timely acquire, develop and introduce new products or product enhancements that will be accepted by the market. If clinical trials of our current or future product candidates do not produce results necessary to support regulatory approval in the United States, we will be unable to commercialize these products. If our acquisitions are unsuccessful, our business may be harmed. Our reliance on single source suppliers could limit our ability to meet demand for our products in a timely manner or within our budget. We are dependent on the services of Alexis V. Lukianov and Keith Valentine, and the loss of either of them could harm our business. If we fail to properly manage our anticipated growth, our business could suffer. If we fail to obtain, or experience significant delays in obtaining, FDA clearances or approvals for our future products or product enhancements, our ability to commercially distribute and market our products could suffer. The safety of our products is not yet supported by long-term clinical data and our products may therefore prove to be less safe and effective than initially thought. If we or our suppliers fail to comply with the FDA s quality system regulations, the manufacture of our products could be delayed and we may be subject to an enforcement action by the FDA. Risks Related to Our Financial Results and Need for Financing We may be unable to grow our revenue or earnings as anticipated, which may have a material adverse effect on our future operating results. The financial crisis and general slowdown of the economy may adversely affect our liquidity and the liquidity of our customers. Our quarterly financial results are likely to fluctuate significantly because our sales prospects are uncertain. Upon the achievement of certain milestones related to our acquisitions, we may be required to make payments which may affect our liquidity and our financial results. We expect our operating expenses to continue to increase as we attempt to expand into international markets, which could disrupt our U.S. business operations, present risks not originally contemplated and harm our operating results. Risks Related to Our Intellectual Property and Potential Litigation We are currently involved in a patent litigation action involving Medtronic and, if we do not prevail in this action, we could be liable for past damages and might be prevented from making, using, selling, offering to sell, importing or exporting certain of our products. Our ability to protect our intellectual property and proprietary technology through patents and other means is uncertain. If we become subject to product liability claims, we may be required to pay damages that exceed our insurance coverage. Any claims relating to us making improper payments to physicians for consulting services, or other potential violations of laws or regulations governing interactions between us and healthcare providers, could be time consuming and costly. We or our suppliers may be the subject of claims for non-compliance with FDA regulations in connection with the processing or distribution of allograft products. Risks Related to the Securities Markets and Ownership of Our Common Stock We expect that the price of our common stock will fluctuate substantially, potentially adversely affecting the ability of investors to sell their shares.

Full 10-K form ▸

1142596--2/26/2010--NUVASIVE_INC