среда, 18 мая 2011 г.

Milestone Scientific Receives FDA Clearance Of Single Tooth Anesthesia Device

Milestone
Scientific Inc. (Amex: MSS), which develops, manufactures, and markets
'intelligent' computer controlled local anesthetic delivery systems, today
announced that it has received FDA 510(k) Premarket Notification clearance
for the marketing and sale of its Single Tooth Anesthesia Device (STA).


The STA is a Computer Controlled Local Anesthesia Delivery Device that
utilizes Milestone Scientific's patented CompuFlo pressure measuring
technology to provide audible and visual "biofeedback" to the dentist by
measuring the pressure at the tip of the needle. The device is designed to
significantly improve the efficiency and economics of the dental office.
The periodontal ligament (PDL) injection, which anesthetizes only the tooth
that requires repair, is generally thought to be the most valuable
injection for the dentist, the patient and the business of dentistry.
Because PDL injections are very difficult for most dentists to administer
using current techniques and can be extremely painful for the patient,
dentists typically assure effective anesthetic administration by using a
"mandibular block" that anesthetizes a quarter of the face in addition to
the single tooth being worked on. Unfortunately, dentists 'miss' the
targeted area for the anesthesia about 30% of the time, requiring multiple
injections and more patient time in the chair. In addition, "block"
anesthesia inconveniences the patient in a number of ways; the lip, tongue
and inside of the cheek are made numb as a side effect of this technique;
and when a patient requires anesthesia for work on the opposite side of the
mouth, dentists must currently schedule two separate appointments due to
the impossibility of administering simultaneous mandibular blocks. The STA
device incorporates the "biofeedback" elements of Milestone's patented
CompuFlo technology, thereby allowing dentists to administer injections
accurately into the periodontal ligament space, effectively anesthetizing a
single tooth. While the periodontal ligament injection has been around for
some time, there has been no effective technology that allows dentists to
easily perform the procedure painlessly, safely and predictably until now.


"We are extremely pleased to announce the FDA's acceptance of our
510(k) for the STA device, which we believe has the potential to
revolutionize the administration of local anesthesia in dental offices,"
stated Leonard Osser, Chief Executive Officer of Milestone Scientific Inc.
"Milestone was the first company to introduce 'painless' dentistry with the
introduction of its CompuDent system and disposable Wand handpiece in 1997.
At the time, this represented the most successful launch of a new
anesthesia device in U.S. dentistry, and we have built a solid domestic and
international customer base among dentists who rely upon CompuDent to
assure painless injections. However, although CompuDent did address the
difficulty of administering single-tooth injections, the procedure was
technique-sensitive, which limited its appeal to many dental professionals.
We have addressed this challenge by incorporating 'biofeedback' features
from our CompuFlo technology into the STA device, thereby providing
dentists with audible and visual 'prompts' that make it easy to administer
a PDL injection accurately and painlessly."















"We believe the STA device has the potential to greatly expand
Milestone's share of the dental device market," continued Osser. "The
dentist will now be able to effectively target a single tooth with
anesthesia, increasing the efficiency of his or her practice. The shorter
onset time and predictability of the STA injection should make the dental
practice more profitable. The STA procedure also avoids the collateral
numbness associated with mandibular blocks and shortens the amount of time
the patient must spend in the chair. Because the lips, cheeks and tongue
are not numbed when using a PDL injection, dentists can also work on teeth
that are located on opposite sides of the mouth during the same office
visit, thereby increasing the productivity and revenue potential of dental
practices. Our goal is to introduce the STA in the first quarter of 2007."


As with the Company's CompuDent system, the STA device will generate
recurring revenues from disposable handpieces.


About Milestone Scientific Inc.


Milestone Scientific Inc. is the developer, manufacturer and marketer
of CompuMed(R) and CompuDent(R) computer controlled local anesthetic
delivery systems. These systems comprise a microprocessor controlled drive
unit as well as The Wand(R) handpiece, a single patient use product that is
held in a pen-like manner for injections. The Company also sells the
SafetyWand(R), which incorporates engineered sharps injury protection
features to aid in the prevention of accidental needlesticks. Milestone has
also developed proprietary consumer (Ionic White) and professional
(CoolBlue) teeth whitening systems that were introduced to the market in
early 2005.


Milestone has also received broad United States patent protection on
CompuFlo(TM), an enabling technology for computer controlled, pressure
sensitive infusion, perfusion, suffusion and aspiration that provides real
time displays of pressures, fluid densities and flow rates. CompuFlo
advances the delivery to and/or removal from patients of local anesthesia,
medications and other fluids, and the Company is pursuing market
opportunities in a variety of medical and dental applications. Elements of
CompuFlo technology have been incorporated into the Company's new Single
Tooth Anesthesia (STA) Computer Controlled Local Anesthesia Delivery
Device. CompuFlo and the STA have been cleared for marketing and sale via
the acceptance of 510(k) Premarket Notification filings by the FDA.


The Company is headquartered in Livingston, New Jersey, and its common
stock trades on the American Stock Exchange under the symbol "MSS".



This press release contains forward-looking statements regarding the
timing and financial impact of the Milestone's ability to implement its
business plan, expected revenues and future success. These statements
involve a number of risks and uncertainties and are based on assumptions
involving judgments with respect to future economic, competitive and market
conditions and future business decisions, all of which are difficult or
impossible to predict accurately and many of which are beyond Milestone's
control. Some of the important factors that could cause actual results to
differ materially from those indicated by the forward-looking statements
are general economic conditions, failure to achieve expected revenue
growth, changes in our operating expenses, adverse patent rulings, FDA or
legal developments, competitive pressures, changes in customer and market
requirements and standards, and the risk factors detailed from time to time
in Milestone's periodic filings with the Securities and Exchange
Commission, including without limitation, Milestone's Annual Report on Form
10-KSB for the year ended December 31, 2005. The forward looking-statements
in this press release are based upon management's reasonable belief as of
the date hereof. Milestone undertakes no obligation to revise or update
publicly any forward-looking statements for any reason.


Milestone Scientific Inc.

milesci

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