Quarterly report pursuant to Section 13 or 15(d)

Note 1 - Organization and Business

v3.20.2
Note 1 - Organization and Business
9 Months Ended
Sep. 30, 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
®;
CathCheck
™,
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 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. To date there have been
eleven
 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,
the Company 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. The Company provided an additional data submission to the FDA in
April 2017,
in support of a resubmission
510
(k) application for the device. The
510
(k) original application filed with FDA lapsed in
January 2019.
Following consultation with the FDA Office of Device Evaluation, we intended to file a new
510
(k) application for the device during 
2020.
As of
September 
30,
2020,
the Company has suspended the pursuit of an intra-articular
510
(k) application due to the COVID-
19
Pandemic. The company will revisit this project in
2021.
 
On
April 21, 2020,
Milestone Scientific announced that it had validated and integrated the new CathCheck™ feature into the CompuFlo® Epidural System. Using CathCheck™, physicians and nurses can monitor the placement of a catheter to determine the presence or absence of a pulsatile waveform (heartbeat) providing new information that can be used to determine if the catheter is in place or has become dislodged from the epidural space.
 
On
October 13, 2020,
Milestone Medical announced a Group Purchasing Agreement with Premier, a leading healthcare improvement company, utilizing an alliance of approximately
4,100
U.S. hospitals and
200,000
other providers to transform healthcare. The Agreement, which was effective
November 1, 2020,
allows Premier members, at their discretion, to utilize  pricing and terms pre-negotiated by Premier for the CompuFlo® Epidural System and CathCheck™. The Agreement expires on
February 28, 2022.