APYX Bovie Medical Corp

Risks

• The medical device industry is highly competitive and we may be unable to compete effectively.
• Our industry is highly regulated by the U.S. Food and Drug Administration and international regulatory authorities, as well as other governmental, state and federal agencies which have substantial authority to establish criteria which must be complied with in order for us to continue in operation.
• If we are unable to successfully introduce new products or fail to keep pace with competitive advances in technology, our business, financial condition and results of operations could be adversely affected. In addition, our research and development efforts rely upon investments and alliances and we cannot guarantee that any previous or future investments or alliances will be successful.
• Even if we are successful in developing and obtaining approval for our new product candidates, there are various circumstances that could prevent the successful commercialization of the products.
• Changes in U.S. trade policies could significantly increase the cost of imported goods into the United States, which may materially reduce our sales or profitability.
• Our operations may experience higher costs to produce our products as a result of changes in prices for oil, gasoline and other commodities.
• Our manufacturing facilities are located in Clearwater, Florida and Sophia, Bulgaria and could be affected due to multiple weather risks, including risks to our Florida facility from hurricanes and similar phenomena.
• We rely on certain suppliers and manufacturers for raw materials and other products and are vulnerable to fluctuations in the availability and price of such products and services.
• If we are unable to protect our patents or other proprietary rights, or if we infringe on the patents or other proprietary rights of others, our competitiveness and business prospects may be materially damaged.
• We have been and may in the future become subject to litigation proceedings that could materially and adversely affect our business.
• Our business is subject to the potential for defects or failures associated with our products which could lead to recalls or safety alerts and negative publicity.
• We may, in the future, incur impairments to our long-lived assets.
• We may, in the future, identify deficiencies in controls over financial reporting.
• The market price of our stock has been and may continue to be highly volatile.
• We have no present intention to pay dividends on our common stock and, even if we change that policy, we may be unable to pay dividends on our common stock.
• Historically the low trading volume of our common stock may adversely affect the price of our shares and their liquidity.
• Exercise of options issued by us will dilute the ownership interest of existing stockholders.
• The market price of our stock has been and may continue to be highly volatile.