International Multicenter Study Finds Milestone Scientific's CompuFlo(R) Epidural System Safe Alternative to Traditional Epidural Method
No accidental dural punctures reported using the CompuFlo® Epidural System
Poster Presented at ANESTHESIOLOGY® 2019 Annual Meeting
LIVINGSTON, NJ / ACCESSWIRE / October 21, 2019 / Milestone Scientific Inc. (NYSE:MLSS), a leading developer of computerized drug instruments that provide painless and precise injections, today reported the results of an international multicenter study that compared the accidental dural puncture rate and its complications while using the CompuFlo® Epidural System versus traditional loss of resistance technique in patients under labor epidural analgesia.
This is the first international multicenter study to compare the incidence of accidental dural puncture using the CompuFlo® Epidural System versus the continuous loss of resistance (LOR) technique. The study collected records between 2015 and 2019 of epidural administration on labor and delivery patients using the CompuFlo® Epidural System from four institutions, one in the U.S., one in Chile, and two from Italy. Among the four sites, there were 812 patients who received epidural analgesia with CompuFlo® and none had accidental dural puncture regardless of the composition of the epidural performer types. In comparison, the rate of accidental dural puncture was 5% in the LOR group in the non inferiority trial.
The Company also announced that Professor Rovnat Babazade, MD, University of Texas Medical Branch at Galveston, Department of Anesthesiology, today presented a poster at the ANESTHESIOLOGY® 2019 Annual Meeting in Orlando, Florida. The poster, entitled, "International Multicenter Study of Accidental Dural Puncture Rate; Comparison of the CompuFlo with Traditional Method,'' is available on the Company's website. ANESTHESIOLOGY 2019, hosted by the American Society of Anesthesiologists (ASA), unites more than 14,000 clinicians, thought leaders and professionals from around the world.
Leonard Osser, Interim Chief Executive Officer of Milestone Scientific, commented, "This study is another validation that the CompuFlo epidural instrument is a safe, proven alternative to the loss of resistance technique being used by most medical professionals. Loss of resistance is subjective and consequently associated with failure rates and accidental dural punctures that require further treatment and interventions such as epidural blood patches. The fact that none of the 812 patients who received epidural analgesia with CompuFlo® had an accidental dural puncture is a testament that our technology is effective in accurately identifying the epidural space. We are honored to have the results of this trial presented by Professor Rovnat Babazade at ANESTHESIOLOGY 2019 in front of world leaders in the field of anesthesia."
About Milestone Scientific Inc.
Milestone Scientific Inc. (MLSS) is a biomedical technology research and development company that patents, designs, develops and commercializes innovative diagnostic and therapeutic injection technologies and instruments for medical, dental, cosmetic and veterinary applications. Milestone's computer-controlled systems are designed to make injections precise, efficient, and virtually painless. Milestone's proprietary DPS Dynamic Pressure Sensing technology® is our technology platform that advances the development of next-generation devices, regulating flow rate and monitoring pressure from the tip of the needle, through platform extensions for local anesthesia for subcutaneous drug delivery, with specific applications for cosmetic botulinum toxin injections, epidural space identification in regional anesthesia procedures and intra-articular joint injections. For more information please visit our website: www.milestonescientific.com.
Safe Harbor Statement
This press release contains forward-looking statements regarding the timing and financial impact of Milestone's ability to implement its business plan, expected revenues, timing of regulatory approvals 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, future business decisions and regulatory developments, 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 for the year ended December 31, 2018. 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.
 Gebhard RE. Objective epidural space identification using continuous real time pressure sensing technology: a randomized controlled comparison with fluoroscopy and traditional loss of resistance. Anesthesia & Analgesia. 2018.
David Waldman or Natalya Rudman
Crescendo Communications, LLC
SOURCE: Milestone Scientific Inc.
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Released October 21, 2019