Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands	3 Months Ended	9 Months Ended
Sep. 30, 2018	Sep. 30, 2017	Sep. 30, 2018	Sep. 30, 2017
Net sales	$ 2,246	$ 1,610	$ 5,129	$ 4,855
Cost of sales	1,784	1,001	3,287	3,255
Gross profit	462	609	1,842	1,600
Operating expenses:
Research and development, net of grants	2,672	1,826	7,567	5,622
Clinical and regulatory	964	629	3,439	1,927
Selling and marketing	3,040	2,375	8,931	7,057
General and administrative	2,332	2,528	8,208	8,170
Total operating expenses	9,008	7,358	28,145	22,776
Loss from operations	(8,546)	(6,749)	(26,303)	(21,176)
Interest income	24	33	67	69
Net loss	$ (8,522)	$ (6,716)	$ (26,236)	$ (21,107)
Net loss per common share – basic and diluted (in dollars per share)	$ (0.12)	$ (0.12)	$ (0.41)	$ (0.40)
Weighted average common shares outstanding – basic and diluted (in shares)	68,763	56,799	64,113	53,206

The aggregate total amount of expenses directly related to clinical and regulatory of products and services.

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The aggregate costs related to goods produced and sold and services rendered by an entity during the reporting period. This excludes costs incurred during the reporting period related to financial services rendered and other revenue generating activities.

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The amount of net income or loss for the period per each share in instances when basic and diluted earnings per share are the same amount and reported as a single line item on the face of the financial statements. Basic earnings per share is the amount of net income or loss for the period per each share of common stock or unit outstanding during the reporting period. Diluted earnings per share includes the amount of net income or loss for the period available to each share of common stock or common unit outstanding during the reporting period and to each share or unit that would have been outstanding assuming the issuance of common shares or units for all dilutive potential common shares or units outstanding during the reporting period.

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The aggregate total of expenses of managing and administering the affairs of an entity, including affiliates of the reporting entity, which are not directly or indirectly associated with the manufacture, sale or creation of a product or product line.

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Aggregate revenue less cost of goods and services sold or operating expenses directly attributable to the revenue generation activity.

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Amount of operating interest income, including, but not limited to, amortization and accretion of premiums and discounts on securities.

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The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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Generally recurring costs associated with normal operations except for the portion of these expenses which can be clearly related to production and included in cost of sales or services. Includes selling, general and administrative expense.

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The net result for the period of deducting operating expenses from operating revenues.

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The aggregate costs incurred (1) in a planned search or critical investigation aimed at discovery of new knowledge with the hope that such knowledge will be useful in developing a new product or service, a new process or technique, or in bringing about a significant improvement to an existing product or process; or (2) to translate research findings or other knowledge into a plan or design for a new product or process or for a significant improvement to an existing product or process whether intended for sale or the entity's use, during the reporting period charged to research and development projects, including the costs of developing computer software up to the point in time of achieving technological feasibility, and costs allocated in accounting for a business combination to in-process projects deemed to have no alternative future use.

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Amount, including tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value-added and excise.

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The aggregate total amount of expenses directly related to the marketing or selling of products or services.

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Average number of shares or units issued and outstanding that are used in calculating basic and diluted earnings per share (EPS).

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