Quarterly report pursuant to Section 13 or 15(d)

Organization, Business and Basis of Presentation

Organization, Business and Basis of Presentation
9 Months Ended
Sep. 30, 2016
Notes to Financial Statements  
Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block]
Milestone Scientific Inc. and Subsidiaries, (collectively “
Milestone Scientific”, “our”, “us” or “we”) was incorporated in the State of Delaware in August 1989. Milestone Scientific has developed a proprietary, computer-controlled anesthetic delivery instrument, through the use of
The Wand®,
a single use disposable handpiece. The instrument is marketed in dentistry under the trademark
Wand Plus® and STA (Single Tooth Anesthesia)
and in medicine under the trademark
is suitable for all dental procedures that require local anesthetic.
is suitable for many medical procedures regularly performed in Plastic Surgery, Hair Restoration Surgery, Podiatry, Colorectal Surgery, Dermatology, Orthopedics and a number of other disciplines. The dental instruments are sold in the United States and in over 47 countries abroad. There have been no medical instruments sold in the United States and limited amounts sold internationally as of the reporting date, although certain medical instruments have obtained CE mark approval and now can be marketed and sold in most European countries.   Milestone Scientific’s products are manufactured by a third-party contract manufacturer.
In July 2014, Milestone Scientific acquired all of th
e 750,000 outstanding shares of an inactive Florida corporation and changed its name to Wand Dental, Inc. (“Wand Dental”). In September 2014, that corporation was merged into a Delaware corporation, retaining the same name and capitalization. On July 1, 2014, Wand Dental was capitalized with cash and received Milestone Scientific’s dental business and related dental assets including the exclusive license of Milestone Scientific’s, patents, trademarks, and technology for use in the dental marketplace. Wand Dental is consolidated into Milestone Scientific.
The unaudited consolidated financial statements of Milestone Scientific have been prepared in accordance with accounting principles generally accepted in the United States for interim financial information
. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. These unaudited consolidated financial statements should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 2015 included in Milestone Scientific’s Annual Report on Form 10-K.
In the opinion of management, the accompanying unaudited financial statements contain all adjustment
s (consisting of normal recurring entries) necessary to fairly present Milestone Scientific’s financial position as of September 30, 2016 and the results of its operations for the three and nine months then ended.
The results of operations reported for
the three and nine months ended September 30, 2016 are not necessarily indicative of the results of operations which may be expected for a full year.
In June 2016, a group of investors that participated in our
 May 2014 financing invested an additional $2.0 million in Milestone Scientific through a private placement of one million restricted shares of our common stock, $.001 par value per share (“common stock”), at a price of $2.00 per share.
In the second quarter of
 2016, Milestone Scientific initiated a share exchange program pursuant to which we would exchange one share of common stock for every two outstanding shares of Milestone Medical (described below) common stock, a consolidated variable interest entity.  As of September 30, 2016, 5,035,042 shares of common stock have been issued in exchange for 9,005,000 shares of Milestone Medical common stock.  As a result of these exchanges, at September 30, 2016 Milestone Scientific owns approximately 91% of Milestone Medical.
In July 2
016, Milestone Scientific filed for 510(K) marketing clearance with the US Food and Drug administration (FDA) for marketing clearance of Milestone Medical's (described below) epidural instrument. This clearance is necessary to begin commercialization of this medical instrument in the United States.
In July 2016, Milestone Scientific raised $250,000 in additional capital from the sale of 104,200 shares of common stock at $2.40 per share.
 The Company incurred placement agent fees equal to ten percent of the gross proceeds, or $25,000, which are reflected as an offset against additional paid-in capital as of September 30, 2016. 
            Milestone Scientific has incurred operating losses and negative cash flows from operating activities since its inception, except for 2013. Milestone Scientific is actively pursuing the generation of revenue, positive operating income and net income. The capital raised in May 2014 and June and July 2016 provided Milestone Scientific with the opportunity to continue to develop and commercialize additional medical instruments and aggressively market its dental instruments throughout the world. Milestone Scientific is actively pursuing the generation of positive cash flows from operating activities through an increase in revenue and management believes its cash on hand and remaining net current assets are sufficient to meet its obligations over the next twelve months. Milestone Scientific may need to raise additional capital prior to management’s expected generation of sustainable positive cash flow from operating activities.