Note - ORGANIZATION, BUSINESS AND BASIS OF PRESENTATION

All references in this report to “Milestone Scientific,” “us,” “our,” “we,” or “Milestone”

owner of the following registered U.S. trademarks

: C

Milestone Scientific was incorporated in the State of Delaware in Milestone Scientific has developed a proprietary, computer-controlled anesthetic delivery instrument, through the use of , a single use disposable handpiece. The instrument is marketed in dentistry under the trademark and 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 countries abroad. To date there have been no medical instruments sold in the United States and limited amounts sold internationally, 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 -party contract manufacturer.

During our common stock was listed on the NYSE MKT LLC (“NYSE MKT”) under the ticker symbol “MLSS”.

June

2016,

$2.0

one

$2.00

In the quarter of  Milestone Scientific initiated a share exchange program pursuant to which we exchanged share of common stock for every outstanding shares of Milestone Medical (described below) common stock, a previously consolidated variable interest entity. As a result of the exchange program, at Milestone Scientific owned approximately of Milestone Medical.

In Milestone Scientific raised gross proceeds of in a registered direct offering of shares of common stock at per share.

In Milestone Scientific filed for marketing clearance with the United States Food and Drug Administration ("FDA") Milestone Medical's epidural anesthetic injections instrument. This clearance is necessary to begin commercialization of these medical instruments in the United States.

In we received notification from the FDA that based upon the application submitted for Milestone Scientific's Compu-Flo Intra Articular Computer Controlled Injection System, did not adequately document that the device met the equivalency standard required for clearance. Following consultation with the FDA Office of Device Evaluation, we intend to provide additional data, which could include a new Human Factor Validation study (HFV Study) in support of a new application for the device. An HFV Study demonstrates the ease of use of a product. The cost to generate this incremental data is estimated to be approximately

December

2016,

2,000,000

1,592,775

 shares of common stock, including additional warrants pursuant to a partial exercise of the over-allotment option granted to the underwriters. The public offering price for each share and related warrant was The warrants have a -year term and an exercise price of per share. The gross proceeds from this offering were approximately before deducting underwriting discounts and commissions and other offering expenses.

In in connection with Milestone Scientific public offering of shares in the underwriter of the offering exercised a portion of its over-allotment option and purchased an additional shares of common stock at the public offering price of per share. The gross proceeds to Milestone Scientific from this exercise was approximately before deducting underwriting discounts and commissions and other offering expenses.   

2013.

Scientific is actively pursuing the generation of revenue, positive operating income and net income. The capital raised in and provide Milestone Scientific with the opportunity to continue to develop and commercialize additional medical instruments and aggressively market the dental instruments throughout the world. Milestone Scientific is actively pursuing the generation of positive cash flows from operating activities through an increase in revenue based upon management’s assessment of present contracts and current negotiations and reductions in operating expenses.

twelve

  However, Milestone Scientific need to raise additional capital prior to management's expected generation of sustainable positive cash flow from operating activities.