Quarterly report pursuant to Section 13 or 15(d)

Note 1 - Organization and Business

v3.8.0.1
Note 1 - Organization and Business
9 Months Ended
Sep. 30, 2017
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, 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 instru
ment, 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
47
other countries. 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 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.
 
D
uring
2015,
our common stock was listed on the NYSE MKT under the ticker symbol “MLSS”.
 
 
During
2016,
Milestone Scientific filed for
510
(k) marketing clearance with the 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 instrument 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) 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.
 
In
December 2016,
we completed an underwritten public offering of
2,000,000
shares of c
ommon stock and warrants to purchase up to
1,592,775
 shares of common stock. The public offering price for each share and related warrant was
$1.50.
The gross proceeds from this offering were approximately
$3,000,000,
before deducting underwriting discounts and commissions and other offering expenses.
 
In
January 2017,
the underwriter 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 were approximately
$186,000
before deducting underwriting discounts and commissions and other offering expenses.
In
June 2017,
Milestone Scientific entered into an agreement for the sale of its interest in Milestone China (a
forty
(
40%
) percent interest) (the “
Milestone China Shares”) to an unaffiliated United States domiciled purchaser and a
10
-year option agreement to repurchase the Milestone China Shares. The purchase price for the Milestone China Shares was
$1,400,000
of which
$125,000
was paid in cash and
$1,275,000
was paid by delivery of a non-interest bearing secured promissory note. The note is payable in quarterly installments of
$125,000
 and is secured by the Milestone China Shares until full repayment.  In addition, the purchaser is precluded from selling all or substantially all of its assets prior to repayment of the note. The
10
-year option agreement provides Milestone Scientific an option to repurchase the Milestone China Shares at
$1,400,000
within the
first
two
years and at fair market value (as defined in such agreement) for the remainder of the 
10
-year term. The transaction has been accounted for as a secured financing and Milestone Scientific will continue to account for its relationship with Milestone China under the equity method of accounting. A note receivable is presented on the Company’s balance sheet, along with a deferral from financing transaction (
$1,400,000
). The carrying value of the
forty
(
40%
) percent investment at the transaction date was
zero
(see Note
5
).
 
On
July 13, 2017,
Milestone Scientific consummated a previously disclosed Asset Purchase Agreement (the “
Agreement”) with APAD Octrooi B.V. and APAD B.V. (each, a “Seller” and collectively, the “Sellers”) pursuant to which Milestone Scientific acquired certain patent rights and other intellectual property rights related to the Sellers’ computer controlled injection instrument (the “Purchased Assets”) and has been accounted for as an asset acquisition. On the closing date, Milestone Scientific issued to the Sellers an aggregate of
1,646,358
shares of its common stock, valued at
$2,486,000
for the Purchased Assets which shares are subject to certain post-closing upward or downward adjustments
not
to exceed
twenty-five
percent of the initial shares as of the purchase date or
250,000
Euros, as defined in the agreement. As of 
September 30, 2017,
Milestone Scientific has recorded a 
$167,000
liability relating to the estimated additional shares that would have to be issued according this provision in the Agreement. Milestone Scientific paid approximately
$153,000
in legal fees on behalf of the Seller as stipulated based on the terms of the Agreement. The patents purchased in the amount of
$2,639,000
have been capitalized and will amortized over their
five
year estimated useful life and tested for impairment as a finite lived intangible asset.
 
In
July 2017,
Milestone Scientific's Compensation Committee approved the issuance of
400,000
stock options to Gian Domenico Trombetta, CEO of Wand Dental, a Direc
tor of Milestone Scientific and a director of Innovest S.p.A., an Italian investor (
250,000
options at an exercise price of
$2.55
per share were issued on
July 7, 2017
and
150,000
options having an exercise price at the higher of
$2.55
or the market price of the stock on the date of the
2018
Annual Stockholder meeting, subject to approval of a new or amended equity incentive plan at such meeting.)
 
Milestone Scientific has incurred operating losses and negative cash flows from operating activities in virt
ually each year since its inception. Milestone Scientific is actively pursuing the generation of revenue, positive operating income and net income. The capital raised in
December 2016
and
January 2017
provided Milestone Scientific with working capital to continue to develop its medical instruments and obtain regulatory approval for
one
of its medical instruments ( the
June, 2017
FDA approval of the epidural instrument), as well as to aggressively market its dental instruments. Milestone Scientific is actively pursuing the generation of positive cash flows from operating activities through an increase in revenue from its dental business worldwide, the generation of revenue from its medical instruments and disposables business in the United States (following
June 2017
FDA approval of its
CompuFlo
® Computer Controlled Anesthesia System ) and worldwide, and a reductions in operating expenses. Management believes that Milestone Scientific will have sufficient cash reserves to meet its anticipated obligations over the next
twelve
month period following the date of this report. However, Milestone Scientific will likely  need to raise additional capital prior to the  expected generation of sustainable positive cash flow from operating activities and
may
also need to raise additional capital to effectively launch its approved medical instrument and eventually generate positive cash flow from the anticipated medical business.