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| related topics |
| {product, liability, claim} |
| {customer, product, revenue} |
| {product, market, service} |
| {property, intellectual, protect} |
| {acquisition, growth, future} |
| {operation, international, foreign} |
| {stock, price, operating} |
| {control, financial, internal} |
|
|
If third-party payors do not provide reimbursement for the use of the Powerlink System, our revenues may be negatively impacted
Substantially all of our revenue is generated from a single product, the Powerlink System, and any declines in the sale of this product will negatively impact our business.
We expect to incur losses for the foreseeable future and may never achieve profitability.
Our future operating results are difficult to predict and may vary significantly from quarter to quarter, which may negatively impact our stock price in the future.
Our business is subject to extensive governmental regulation that could make it more expensive and time consuming for us to introduce new or improved products.
We may not receive approval to market the Powerlink System in Japan.
If we fail to increase our direct sales force in a timely manner, our business could suffer.
Our third-party distributors may not effectively distribute our products.
If we fail to properly manage our anticipated growth, our business could suffer.
We rely on a single vendor to supply our graft material for the Powerlink System, and any disruption in our supply could delay or prevent us from producing the product for sale.
If we are unable to protect our intellectual property, our business may be negatively affected.
If our products or processes infringe upon the intellectual property of our competitors, the sale of these products may be challenged and we may have to defend costly and time-consuming infringement claims.
Our sales in international markets subject us to foreign currency exchange and costs which could harm our business.
If we are unable to effectively manage our inventory held on consignment by our intended customers, we will not achieve our expected results.
We may face product liability claims that could result in costly litigation and significant liabilities.
Our operations are capital intensive, and we may need to raise additional funds in the future to fund our operations.
Full 10-K form ▸
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