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| related topics |
| {product, liability, claim} |
| {product, market, service} |
| {operation, natural, condition} |
| {stock, price, operating} |
| {control, financial, internal} |
| {cost, operation, labor} |
| {acquisition, growth, future} |
| {product, candidate, development} |
| {regulation, government, change} |
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The risks and uncertainties described below are not the only ones facing our company. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also impair our business operations. If any of the following risks occur, our business, financial condition or results of operations could be seriously harmed.
We will not be successful if the interventional medical device community does not adopt our new products.
We have limited working capital to pursue our business.
We have a limited history of profitability and may not be profitable in the future.
We may face litigation claims which could prevent us from manufacturing and selling our products or result in our incurring substantial costs and liabilities.
Our future operating results are difficult to predict and may vary significantly from quarter to quarter, which may adversely affect the price of our common stock.
We may face product liability claims that could result in costly litigation and significant liabilities.
The market for interventional medical devices is highly competitive and will likely become more competitive, and our competitors may be able to respond more quickly to new or emerging technologies and changes in customer requirements that may render our products obsolete.
Our international sales are subject to a number of risks that could seriously harm our ability to successfully commercialize our products in any international market.
We have limited manufacturing experience and may encounter difficulties in our manufacturing operations which could seriously harm our business.
Our business and results of operations may be seriously harmed by changes in third-party reimbursement policies.
Our products and our manufacturing activities are subject to extensive governmental regulation that could prevent us from selling our products in the United States or introducing new and improved products
Full 10-K form ▸
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