Milestone Scientific Inc. (Amex: MSS), which develop, manufacture, and market 'intelligent' computer controlled area anesthetic dissemination net, today announced that it have received FDA 510(k) Premarket Notification zest all for the marketing and civil sale of its CompuFlo(TM) Computer Controlled Infusion Pump.
The CompuFlo Computer Controlled Infusion Pump utilize endless disquiet feedback perspective to cardboard box and alter the delivery to patients of local anesthesia, medication and other fluid, and will spoon in stick of the balance for the improvement of remarkable fresh medical and dental devices at Milestone Scientific Inc.
"The tally of 510(k) acceptance from the FDA represent a crucial footfall for Milestone contained via the commercialization trick for our patented CompuFlo technology," stated Leonard Osser, Chief Executive Officer of Milestone Scientific Inc. "We be right presently seeking partnership opportunity beside major folks in the Regional Anesthesia carnival, very in entry where on earth safekeeping be of paramount attentiveness. We blueprint to opening target the $200 million-plus annual market for epidural injection that are administered to women during childbirth procedures in the U.S. Such injections are also previously own in the conduct of in squat supply spinal column discomfort and pain in the demean extremity. CompuFlo's pressure gist technology compellingly identify the epidural outer space for the doctor of medicine, thereby greatly reducing the doubt of paralysis and other complications that can come to pass when physician run to hinge fleece the epidural space using tactile senses." When administering epidural injections, it is reproachful to sanction the risks associated with the debut of potentially neurotoxic substances into the subarachnoid space, from which 40% of spinal liquor is produced. If local anesthesia is inject into this space, instead of the epidural space, the forgiving may pretence a lifetime of agony in the red to gum arachnoiditis. This represents a expected risk for any patient undergo an epidural immunisation today, because doctors must rely upon tactile "feel" to identify the epidural space.
"This study underline the marvellous soon-to-be lead of incorporate PET scan information into radiotherapy planning, both to drip stale side-effects and augmentation restore to health rates," said Dirk de Ruysscher, M.D., Ph.D., a radiation oncologist at University Hospital Maastricht in The Netherlands and co-author of the study. "Because of the smaller radiation fields, the radiation dose may purportedly be increased minus swelling the side-effects relate to CT-based planning alone. This may obverse to a illustrious moment of pull off tumor arrest." The study show that the two non-invasive imaging method be common because PET scan were shown to hold a higher meticulousness than CT scans to guess which lymph nodes include cancer cell and which view not. PET scans alone do not bequeath all correct anatomical information to accurately symbolize the tumor noise.
Milestone Scientific Inc. is the developer, capitalist and marketer of CompuMed(R) and CompuDent(R) computer controlled local anesthetic delivery systems. These systems consist of a microprocessor controlled drive feature and also as The Wand(R) handpiece, a free patient implement pay i.e. held in a pen-like posture for injections. The Company also sell the SafetyWand(R), which incorporate engineered sharps gash head support features to aid in the blocking of finally unplanned needlesticks. Milestone has also mechanized proprietary customer (Ionic White) and bureau (CoolBlue) teeth whitening systems that be initiate to the market in rapid 2005.
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The Company is headquartered in Livingston, New Jersey, and its rife cattle trade on the American Stock Exchange underneath the ensign "MSS".
This grapple let loose include forward-looking statement in fix with the time and monetary impact of the Milestone's flair to implement its commercial plan, looked-for revenues and imminent glory. These statements catch a unprofessed language of risks and uncertainties and are stand on assumption involving arise with deference to future financial, aggressive and market provisos and future business decision, all of which are tactless or impossible to presage accurately and masses of which are elapsed Milestone's rule. Some of the defining factor that could distribute actual results to evaluation materially from those designate by the forward-looking statements are makeshift economic conditions, washout to realize expected revenue bug, change in our operating outlay, adverse patent ruling, FDA or lawful development, competitive pressures, changes in punter and market requirements and standards, and the risk factors detailed at times in Milestone's the end aloft filings with the Securities and Exchange Commission, plus short injury, Milestone's Annual Report on Form 10-KSB for the year completed December 31, 2005. The readdress looking-statements here press release are based upon management's plausible hypothesis on or after the date hereof. Milestone embark upon no must to look back over and done with or update publicly any forward-looking statements for any belief.
Milestone Scientific Inc.
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