Milestone Scientific Receives 510(k) Premarket Notification Acceptance From FDA for CompuFlo(TM) Computer Controlled Infusion P
13 Juli 2006 - 6:44PM
PR Newswire (US)
Company to Pursue Strategic Relationships With Marketing Leaders in
Medical Field 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 Pump. 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 field." "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 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. 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.
CONTACT Leonard Osser, CEO Milestone Scientific Inc. (973)
535-2717; (973) 535-2829 (Fax) Web site: http://www.milesci.com/
DATASOURCE: Milestone Scientific Inc. CONTACT: Leonard Osser, CEO
of Milestone Scientific Inc., +1-973-535-2717, or fax,
+1-973-535-2829 Web site: http://www.milesci.com/
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