Quarterly report pursuant to Section 13 or 15(d)

Note 1 - Organization and Business

v3.19.1
Note 1 - Organization and Business
3 Months Ended
Mar. 31, 2019
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 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
five
 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
2019.
 
In
November 2018,
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, 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.
 
In
February 2019,
Milestone Scientific consummated a public offering and a private placement of Common Stock. The public offering generated gross proceeds of approximately
$2.0
million for the issuance of
5,715,000
shares of common stock and warrants to purchase
1,428,750
shares of common stock. The warrants term is
5
 years and they are exercisable at
$.50.
Subsequent to the public offering the underwriter exercised its overallotment option and paid approximately
$198,000
for 
567,400
additional shares of common and as well as
141,850
warrants.
 
Also, in
February 2019,
the Company generated gross proceeds from a private placement of approximately
$250,000
for
714,286
shares of common stock and warrants to purchase
178,571
shares of common stock from  
Bp4
 S.p.A., a principal stockholder of Milestone Scientific, that exercised its right to participate on a pro-rata basis on the recent public offering.
Bp4’s
CEO is a director of Milestone Scientific and also Chief Executive Officer and Director of Wand Dental, a wholly owned subsidiary of Milestone Scientific. The warrants term is
5
 years and they are exercisable at
$.50.