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related topics |
{product, liability, claim} |
{regulation, government, change} |
{acquisition, growth, future} |
{product, candidate, development} |
{product, market, service} |
{control, financial, internal} |
{operation, natural, condition} |
{customer, product, revenue} |
{property, intellectual, protect} |
{condition, economic, financial} |
{cost, operation, labor} |
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We may not be able to sustain or manage our growth.
We may not be able to timely re-establish our newly acquired Ortho Wound products in the marketplace and further, we expect to incur significant operating losses in the future.
We face significant competition from established competitors in the medical device industry.
Increases to the size of our U.S. direct sales force may not generate desired increases in revenues.
We may not be able to adequately enforce or protect our intellectual property rights or to protect ourselves against the infringement claims of others.
Oversight of the medical device industry might affect the manner in which we may sell medical devices.
Our failure to obtain regulatory clearance/approval and maintain regulatory compliance for any of our products would impact our ability to generate revenue from those products.
Because many of our biomaterial products are manufactured from bovine pericardium, perceptions about Bovine Spongiform Encephalopathy may impact our sales.
We may face the risk of product liability claims and product recalls that could result in costly and time consuming litigation and significant liability.
Due to the unpredictability of the health care industry, our customers may not be able to receive third-party reimbursement for the medical procedures utilizing our products.
Healthcare reform legislation could adversely affect our revenue and financial condition.
The current global economic downturn could continue to adversely impact our business.
We depend on highly specialized equipment to manufacture our products and loss of or damage to one of our manufacturing facilities could result in reduced revenues and significant losses.
We cannot predict the outcome of our clinical studies.
Our strategy to acquire complementary businesses and technologies involves risk and may result in disruptions to our business by, among other things, distracting management time and diverting financial resources.
Full 10-K form ▸
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