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related topics |
{product, liability, claim} |
{customer, product, revenue} |
{operation, international, foreign} |
{product, market, service} |
{property, intellectual, protect} |
{loss, insurance, financial} |
{personnel, key, retain} |
{acquisition, growth, future} |
{stock, price, operating} |
{cost, contract, operation} |
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Modifications to our marketed devices may require FDA regulatory clearances or approvals or require us to cease marketing or recall the modified devices until such clearances or approvals are obtained.
If market clearance is not obtained for launch of the CONSERVE
Plus implant in the U.S., growth of our hip product line could be impacted.
Our biologics business is subject to emerging governmental regulations that can significantly impact our business.
If we fail to compete successfully in the future against our existing or potential competitors, our sales and operating results may be negatively affected and we may not achieve future growth.
If we lose one of our key suppliers, we may be unable to meet customer orders for our products in a timely manner or within our budget.
We derive a significant portion of our sales from operations in international markets that are subject to political, economic and social instability.
Efforts to acquire and integrate other companies or product lines could adversely affect our operations and financial results.
If our patents and other intellectual property rights do not adequately protect our products, we may lose market share to our competitors and be unable to operate our business profitably.
If we lose any existing or future intellectual property lawsuits, a court could require us to pay significant damages or prevent us from selling our products.
If product liability lawsuits are brought against us, our business may be harmed.
If we are unable to continue to develop and market new products and technologies, we may experience a decrease in demand for our products or our products could become obsolete, and our business would suffer
Our business could suffer if the medical community does not continue to accept allograft technology.
If adequate levels of reimbursement from third-party payors for our products are not obtained, surgeons and patients may be reluctant to use our products and our sales may decline.
If surgeons do not recommend and endorse our products, our sales may decline or we may be unable to increase our sales and profits.
We rely on our independent sales distributors and sales representatives to market and sell our products.
Fluctuations in insurance cost and availability could adversely affect our profitability or our risk management profile.
If we cannot retain our key personnel, we will not be able to manage and operate successfully and we may not be able to meet our strategic objectives.
If a natural or man-made disaster strikes our manufacturing facilities, we could be unable to manufacture our products for a substantial amount of time and our sales could decline.
Our business plan relies on certain assumptions about the market for our products, which, if incorrect, may adversely affect our profitability.
Fluctuations in foreign currency exchange rates could result in declines in our reported sales and earnings.
Our quarterly operating results are subject to substantial fluctuations and you should not rely on them as an indication of our future results.
Full 10-K form ▸
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