Quarterly report pursuant to Section 13 or 15(d)

Note 1 - Organization, Business and Basis of Presentation

v3.7.0.1
Note 1 - Organization, Business and Basis of Presentation
3 Months Ended
Mar. 31, 2017
Notes to Financial Statements  
Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block]
Note
1
- ORGANIZATION, BUSINESS AND BASIS OF PRESENTATION
 
 
All references in this report to “Milestone Scientific,” “us,” “our,” “we,” or “Milestone”
refer to Milestone Scientific Inc., and its consolidated subsidiaries, Wand Dental, Milestone Advanced Cosmetic, Milestone Medical, and Milestone Education (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 instrument, through the use of
The Wand®
, a single use disposable handpiece. The instrument 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 a number of other disciplines. The dental instruments are sold in the United States and in over
47
countries abroad. To date there have been no medical instruments sold in the United States and limited amounts sold internationally, although certain medical instruments have obtained CE mark approval and now can be marketed and sold in most European countries.   Milestone Scientific's products are manufactured by a
third
-party contract manufacturer.
 
During
2015,
our common stock was listed on the NYSE MKT LLC (“NYSE MKT”) under the ticker symbol “MLSS”.
 
In
June
2016,
we raised an additional
$2.0
million of gross proceeds in a private placement of
one
million shares of common stock, at a price of
$2.00
per share.
In the
second
quarter of 
2016,
Milestone Scientific initiated a share exchange program pursuant to which we exchanged
one
share of common stock for every
two
outstanding shares of Milestone Medical (described below) common stock, a previously consolidated variable interest entity. As a result of the exchange program, at
March
31,
2017,
Milestone Scientific owned approximately
96%
of Milestone Medical.
In
July
2016,
Milestone Scientific raised gross proceeds of
$250,000
in a registered direct offering of
104,200
shares of common stock at
$2.40
per share.
 
In
July
2016,
Milestone Scientific filed for
510(k)
marketing clearance with the United States Food and Drug Administration ("FDA") Milestone Medical's epidural anesthetic injections instrument. This clearance is necessary to begin commercialization of these medical instruments in the United States.
 
In
December
2016,
we received notification from the FDA that based upon the
510(k)
application submitted for Milestone Scientific's Compu-Flo Intra Articular Computer Controlled Injection System, did not adequately document that the device met the equivalency standard required for
510(k)
clearance. Following consultation with the FDA Office of Device Evaluation, we intend to provide additional data, which could include a new Human Factor Validation study (HFV Study) in support of a new
510(k)
application for the device. An HFV Study demonstrates the ease of use of a product. The cost to generate this incremental data is estimated to be approximately
$100,000.
 
In
December
2016,
we completed an underwritten public offering of
2,000,000
shares of common stock and warrants to purchase up to
1,592,775
 shares of common stock, including
92,775
additional warrants pursuant to a partial exercise of the over-allotment option granted to the underwriters. The public offering price for each share and related warrant was
$1.50.
The warrants have a
three
-year term and an exercise price of
$2.55
per share. The gross proceeds from this offering were approximately
$3,000,000,
before deducting underwriting discounts and commissions and other offering expenses.
 
In
January
2017,
in connection with Milestone Scientific public offering of shares in
December
2016,
the underwriter of the offering exercised a portion of its over-allotment option and purchased an additional
123,700
shares of common stock at the public offering price of
$1.499
per share. The gross proceeds to Milestone Scientific from this exercise was approximately
$186,000
before deducting underwriting discounts and commissions and other offering expenses.   
 
Milestone Scientific has incurred operating losses and negative cash flows from operating activities since its inception, except for
2013.
Milestone
Scientific is actively pursuing the generation of revenue, positive operating income and net income. The capital raised in
December
2016
and
January
2017,
provide Milestone Scientific with the opportunity to continue to develop and commercialize additional medical instruments and aggressively market the dental instruments throughout the world. Milestone Scientific is actively pursuing the generation of positive cash flows from operating activities through an increase in revenue based upon management’s assessment of present contracts and current negotiations and reductions in operating expenses.
Management believes that Milestone Scientific will have sufficient cash reserves to meet its anticipated obligations over the next
twelve
months from the issuance date of this report.
  However, Milestone Scientific
may
need to raise additional capital prior to management's expected generation of sustainable positive cash flow from operating activities.