Quarterly report pursuant to Section 13 or 15(d)

Note 1 - Organization and Business

v3.10.0.1
Note 1 - Organization and Business
9 Months Ended
Sep. 30, 2018
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 Devices, 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 Device®; 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 Device®
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
53
 other countries. To date, there have been minimal sales of the Company’s medical devices in the United States and Europe. 
 
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 (the “
CompuFlo
Epidural System”).  In
June 2017,
the FDA approved the
CompuFlo
Epidural System for epidural injections.  Milestone Scientific is in the process of meeting 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 filed a new
510
(k) application for the device in
June 2018.
In
August 2018,
the FDA provided Milestone Scientific with a  list of questions on the intra-articular
510
(k) application filed in
June 2018.
Milestone Scientific is in the process of reviewing and responding to FDA questions.