Milestone Scientific Receives FDA Clearance Of Single Tooth Anesthesia Device
LIVINGSTON, N.J., Aug. 15 /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 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.
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/