849778--2/22/2006--CYTYC

related topics

{product, liability, claim}

{product, candidate, development}

{acquisition, growth, future}

{customer, product, revenue}

{competitive, industry, competition}

{personnel, key, retain}

{regulation, government, change}

{operation, international, foreign}

{condition, economic, financial}

{property, intellectual, protect}

{control, financial, internal}

{provision, law, control}

{stock, price, operating}

{cost, regulation, environmental}

We depend principally on the sale of three product lines. Our sales are dependent on third-party reimbursement. We are dependent upon a relatively small number of large clinical laboratory customers in the United States for a significant portion of our sales of the ThinPrep System. Our business faces intense competition from other companies. The success of our business depends on our ability to protect our intellectual property rights. If breast surgeons, radiation oncologists and patients do not adopt the MammoSite System as a preferred treatment for early-stage breast cancer, the intended benefits of our acquisition of Proxima may not be realized and the market price of our common stock could decline. Current levels of growth in the market for new endometrial ablation procedures for the treatment of excessive menstrual bleeding may not be indicative of future growth. We cannot accurately predict the rates at which women will undergo the NovaSure procedure. Our success depends on the continued market acceptance of our ThinPrep System products and their cost. Our success depends on our ability to manage growth effectively. We may not be able to successfully integrate future acquisitions. Future acquisitions may also harm our operating results, dilute our stockholders equity and create other financial difficulties for us. We may be subject to the risk of product liability claims relating to our products. Our quarterly operating results may fluctuate. We currently have limited international sales capabilities and cannot guarantee success in international markets. We are highly dependent on key personnel. Our reliance on single source or limited source suppliers could harm our business. Our lack of redundant manufacturing capabilities could harm our business. Because a component of the NovaSure System is manufactured in Costa Rica, we will be subject to the political and economic risks of doing business there. We are subject to numerous FDA laws and regulations, and non-compliance with such laws, as well as changes in such laws or future interpretations of such laws, could cause us to incur significant compliance costs and/or subject us to significant civil and criminal sanctions. We cannot guarantee we will obtain or maintain necessary regulatory approvals for our products. If we or our contract manufacturers fail to comply with the FDA s Quality System Regulation, manufacturing operations could be interrupted, and our product sales and operating results could be adversely affected. Our products may be subject to recalls even after receiving FDA clearance or approval, and if a recall occurs, the reputation of our products and our operating results could be adversely affected. Some of our activities may subject us to risks under federal and state laws prohibiting kickbacks and false or fraudulent claims. Certain provisions of our certificate of incorporation, bylaws and Delaware law may delay or prevent a change in control of our company.

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849778--2/22/2006--CYTYC_CORP