LIVINGSTON, N.J., July 13 /PRNewswire-FirstCall/ -- 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 acceptance
for the marketing and sale of its CompuFlo(TM) Computer Controlled Infusion
The CompuFlo Computer Controlled Infusion Pump utilizes pressure
feedback data to monitor and regulate the delivery to patients of local
anesthesia, medications and other fluids, and will serve as the foundation
for the development of significant new medical and dental devices at
Milestone Scientific Inc.
"The receipt of 510(k) acceptance from the FDA represents a major step
for Milestone in the commercialization process for our patented CompuFlo
technology," stated Leonard Osser, Chief Executive Officer of Milestone
Scientific Inc. "We are currently seeking partnership opportunities with
major companies in the Regional Anesthesia market, especially in
applications where safety is of paramount concern. We plan to initially
target the $200 million-plus annual market for epidural injections that are
administered to women during childbirth procedures in the U.S. Such
injections are also used in the treatment of low back pain and pain in the
lower extremities. CompuFlo's pressure sensing technology clearly
identifies the epidural space for the doctor, thereby greatly reducing the
risks of paralysis and other complications that can occur when physicians
attempt to locate the epidural space using tactile senses."
When administering epidural injections, it is critical to recognize the
risks associated with the introduction of potentially neurotoxic substances
into the subarachnoid space, from which 40% of spinal fluid is produced. If
local anesthesia is injected into this space, instead of the epidural
space, the patient may face a lifetime of agony due to adhesive
arachnoiditis. This represents a potential risk for any patient undergoing
an epidural injection today, because doctors must rely upon tactile "feel"
to identify the epidural space.
"Clinical studies using Milestone's CompuFlo Computer Controlled
Infusion Pump in the administration of epidural anesthesia have provided
highly encouraging results," noted Thomas Ronca, President and Chief
Operating Officer of the Company. "We believe that, because of the risks
associated with current epidural injection techniques, CompuFlo has the
potential to become a 'standard of care' within the anesthesiology
profession. Our next step is to identify and enter into strategic
relationships with one or more marketing leaders in the medical device
"The now-approved CompuFlo infusion pump also underlies the development
of our Single-Tooth Anesthesia ("STA") device," continued Ronca. "We
believe the STA device can revitalize our entire line of dental anesthetic
delivery systems and promote significantly increased usage of our systems
and their single-use 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
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.
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.
Leonard Osser, CEO
Milestone Scientific Inc.
(973) 535-2717; (973) 535-2829 (Fax)
Web site: www.milesci.com
SOURCE Milestone Scientific Inc.