Milestone Scientific Receives 510(k) Premarket Notification Acceptance From FDA For CompuFlo(TM) Computer Controlled Infusion Pump
LIVINGSTON, N.J., July 13 /PRNewswire-FirstCall/ -- Milestone Scientific Inc. , 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: www.milesci.comMilestone 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/