Annual report pursuant to Section 13 and 15(d)

Note A - Organization and Business

v3.19.1
Note A - Organization and Business
12 Months Ended
Dec. 31, 2018
Notes to Financial Statements  
Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block]
NOTE A — ORGANIZATION AND BUSINESS
 
All references in this report to “Milestone Scientific,” “us,” “our,” “we,” the “Company” or “Milestone” refer to Milestone Scientific Inc., and its consolidated subsidiaries, Wand Dental, Inc., Milestone Advanced Cosmetic Systems, Inc., Milestone Medical, Inc. and Milestone Education LLC (all described below), unless the context otherwise indicates. Milestone Scientific is the owner of the following registered U.S. trademarks: C
ompuDent®; CompuMed®; CompuFlo®; DPS Dynamic Pressure Sensing technology®; Milestone Scientific ®; the Milestone logo ®; SafetyWand®; STA Single Tooth Anesthesia System®; and The Wand ®.
 
 
Milestone Scientific was incorporated in the State of Delaware in
August 1989.
Milestone Scientific has developed a proprietary, computer-controlled anesthetic delivery device, using
The Wand®
, a single use disposable handpiece. The device is marketed in dentistry under the trademark
CompuDent®,
and
STA Single Tooth Anesthesia System®
and in medicine under the trademark
CompuMed®. CompuDent®
is suitable for all dental procedures that require local anesthetic.
CompuMed®
is suitable 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. To date there have been
five
 (
5
) 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
June 2017, 
Milestone Scientific received
510
(k) marketing clearance from the U.S. Food and Drug Administration (FDA) on the
CompuFlo
® Epidural Computer Controlled Anesthesia System (“Epidural”).
 
During
2016,
Milestone Scientific filed for
510
(k) marketing clearance with the 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.
 
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
2019.
 
In
November 20, 2018,
Milestone Scientific Inc. 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, 2018,
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 still
not
in compliance with Section(s)
1003
(a)(i), (ii) and (iii) of the Company Guide and its listing on the Exchange is being continued pursuant to an extension granted by the Exchange.