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Note 1 - Organization and Business | 3 Months Ended
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Mar. 31, 2020
Notes to Financial Statements |
Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block] | NOTE 1 — ORGANIZATION AND BUSINESS All references in this report to “Milestone Scientific, Inc.,” “us,” “our,” “we,” the “Company “or “Milestone” refer to Milestone Scientific Inc., and its consolidated subsidiaries, Wand Dental, Inc., Milestone Advanced Cosmetic Inc. and Milestone Medical Inc. and affiliate, Milestone Education LLC, unless the context otherwise indicates. Milestone Scientific is the owner of the following registered U.S. trademarks: CompuDent ® ; CompuMed ® ; CompuFlo ® ; DPS Dynamic Pressure Sensing technology ® ; Milestone Scientific ® ; the Milestone logo ® ; Safety Wand ® ; STA Single Tooth Anesthesia System ® ; and The Wand ® . Milestone Scientific was incorporated in the State of Delaware in August 1989. Milestone Scientific is a medical technology research and development company that patents, designs, develops and commercializes innovative diagnostic and therapeutic injection technologies and devices for medical, dental, cosmetic and veterinary applications. Since our inception, we have engaged in pioneering proprietary, innovative, computer-controlled injection technologies and solutions for the medical and dental markets. Milestone Scientific has developed a proprietary, computer-controlled anesthetic delivery device, using The Wand® , a single use disposable handpiece. The device is marketed in the dental market under the trademark CompuDent®, and STA Single Tooth Anesthesia System® and in the medical market under the trademark CompuMed®. CompuDent® is suitable, for all dental procedures that require local anesthetic. CompuMed® is suitable upon regulatory approval, as required, for many medical procedures regularly performed in Plastic Surgery, Hair Restoration Surgery, Podiatry, Colorectal Surgery, Dermatology, Orthopedics and many other disciplines. The dental devices are sold in the United States, Canada and in 60 other countries. During 2016, Milestone Scientific filed for 510 (k) marketing clearance with the U.S. Food and Drug Administration (FDA) for both intra-articular and epidural injections with the CompuFlo ® Computer Controlled Anesthesia System. In June 2017, the FDA approved the CompuFlo ® Epidural Computer Controlled Anesthesia System for epidural injections. Milestone Scientific is in the process of introductory meetings with medical device distributors within the United States and foreign markets. Milestone Scientific’s immediate focus is on marketing its epidural device throughout the United States and Europe. To date there have been elevem medical devices sold in the United States and limited amounts sold internationally, although certain medical devices have obtained CE mark approval and can be marketed and sold in most European countries. In December 2016, we received notification from the FDA that based upon the 510 (k)-application submitted for intra- articular injections, we did not adequately document that the device met the equivalency standard required for 510 (k) clearances. Following consultation with the FDA Office of Device Evaluation, we intend to file a new 510 (k) application for the device in 2020, subject to sufficient funds being available. In November 2019 , Milestone Scientific received a letter from NYSE American LLC (the “Exchange”) stating that the Company was not in compliance with the continued listing standards as set forth in Section(s) 1003 (a)(i), (ii), and (iii) of the NYSE American Company Guide (the “Company Guide”).On December 20, 2019 , the Company submitted a plan of compliance (the “Plan”) to the Exchange addressing how it intends to regain compliance with Section(s) 1003 (a)(i), (ii) and (iii) of the Company Guide by May 20, 2020. On January 24, 2019, the Company received a letter from the Exchange stating that the Company’s Plan has been accepted by the Exchange. The Company is not yet in compliance with Section(s) 1003 (a)(i), (ii) and (iii) of the Company Guide and does not expect to be in compliance by the May 20th requirement. The coronavirus (COVID- 19 ) that was reported to have surfaced in Wuhan, China in December 2019 and that has now spread to other countries throughout the world has and is expected to adversely impact our operations and those of our third -party partners. Additionally, the continued spread of the virus could negatively impact the manufacture, supply, distribution and sale of our products. As a result of the reduced hours and closings of dental offices throughout the country and the rest of the world due to the continuing spread of COVID- 19, we anticipate that our revenue for the second quarter, and possibly the third quarter, will be adversely affected. At this point in time, it is too early to determine an estimate of what those impacts will be, or the effect COVID- 19 may have on our fourth quarter revenue. In addition, it is too early to determine what the effect will be on the anticipated commercialization of our CompuFlow Epidural system as a medical device during 2020. The extent to which the coronavirus impacts our operations or those of our third -party partners also depend on future developments which are still highly uncertain and cannot be predicted with confidence at this time. Such future developments could have a material adverse effect on our financial results and our ability to conduct business as expected.

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