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Note 1 - Organization and Business
3 Months Ended
Mar. 31, 2021
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,” “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 approximately
60
other countries. 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. Through 
March 31, 2021
to date there have been
twelve
 medical devices sold in the United States and limited amounts sold internationally.
 
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 intended to file a new
510
(k) application for the device in
2019,
however, due to financing constraints, a new
510
(k) application was
not
filed in
2019
or 
2020.
As of
March 31, 2021,
the Company has decided
not
to proceed with securing the FDA approval for the intra-articular instrument at this time. Milestone Medical's immediate focus is on marketing its epidural device throughout the United States and Europe.
 
In
April
and
June
of
2020,
the Company completed
two
Common Stock offerings generating net proceeds of approximately
$4.6
 million and
$13.4
million, respectively (see Note
9
). As of
March 31, 
2021,
cash on hand was approximately
$16.9
 million, an increase of
$2.7
 million from
December 31, 2020.