Milestone Scientific, Inc. Announces Successful Epidural Clinical Study Using Its CompuFlo(TM) Technology
LIVINGSTON, N.J., Nov. 1 /PRNewswire-FirstCall/ -- Milestone Scientific, Inc. , today announced that successful results of an independent pilot clinical study have confirmed the efficacy of its CompuFlo(TM) pressure/force computer controlled anesthetic delivery system in identifying the epidural space. Identifying when a hypodermic needle has entered the epidural space is a critically important factor in the safety and effectiveness of anesthetic injections administered during childbirth and in the course of pain management therapy. A report on the results of the study, conducted through the University of Texas Health Science Center at Houston under the guidance of Dr. Oscar Ghelber, Assistant Professor of Anesthesiology, was presented at the Society for Technology in Anesthesia (STA) meeting on October 28th in Las Vegas, Nevada. Proper and consistent identification of the epidural space represents a critical step towards the adoption of Milestone's technology for the administration of epidural anesthesia.
Currently, doctors attempt to identify the epidural space through a subjective technique known as "loss of resistance". This technique requires that medical practitioners use their thumb to "sense" a change in pressure in determining if they have reached the epidural space. The epidural space is mis-identified in a significant percentage of procedures performed with this method, which may result in complications that can include infection, paralysis and, in extreme cases, death.
Milestone's CompuFlo system used in the study detects pressure changes as the needle penetrates human tissue with differing characteristics. In each case, the epidural space was successfully and clearly identified by the CompuFlo system. False readings resulting from anatomical differences in patients were also clearly identified by CompuFlo's pressure sensing technology.
"This represents an exciting development, as the scientific data appears to validate the underlying core technology that we have worked so hard to develop", commented Dr. Mark Hochman, Director of Clinical Affairs at Milestone Scientific, Inc. and inventor of the CompuFlo technology.
"We believe that our CompuFlo system represents a technological breakthrough that has the potential to change medical practice, resulting in decreased patient risk and lower costs associated with epidural injections," commented Leonard Osser, Chief Executive Officer of Milestone Scientific, Inc. "Of the more than 4.5 million women who undergo childbirth procedures each year in the U.S., almost one third (1.5 million) refuse epidural anesthesia due to the risk of complications. The successful completion of additional independent clinical studies now underway should provide Milestone with an important, clinically validated, patented technology that addresses a potentially large new market opportunity in the medical field."
About Milestone Scientific, Inc.
Milestone Scientific is the developer, manufacturer and marketer of CompuMed(R) and CompuDent(R) computer controlled local anesthetic delivery systems for medical and dental applications. These systems are comprised of a microprocessor controlled drive unit and single patient use disposable handpieces. The Company recently announced its entry into the consumer tooth whitening market via the licensing of its proprietary CoolBlue system to a third party mass-marketing organization. Milestone has also developed and patented its CompuFlo(TM) technology, which advances the delivery and removal of a wide array of fluids from the human body by providing real time displays of pressures, fluid densities and flow rates. In 2002, Milestone Scientific received United States patent protection on a safety engineered sharps technology that allows for fully automated true single-handed activation with needle anti-deflection and force-reduction capability. In 2003, Milestone received FDA Clearance to market SafetyWand(R), which incorporates engineered sharps injury protection features to aid in the prevention of accidental needlesticks.
The Company is headquartered in Livingston, New Jersey, and its common stock trades on the American Stock Exchange under the symbol "MS". For additional information, please visit the Company's website at http://www.milesci.com/.
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, 2003. 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.
For further information, please contact Stuart J. Wildhorn, President of Milestone Scientific, Inc., +1-973-535-2717, or fax, +1-973-535-2829.Milestone Scientific, Inc.
CONTACT: Stuart J. Wildhorn, President of Milestone Scientific, Inc.,+1-973-535-2717, or fax, +1-973-535-2829
Web site: http://www.milesci.com/