SOURCE: Milestone Scientific, Inc.

Milestone Scientific, Inc.

August 19, 2015 09:32 ET

Milestone Scientific's Epidural & Intra-Articular Subsidiary Announces Successful Interim Analysis of Clinical Trials for Its Epidural Instrument

Interim Analysis Achieves Goal Set by the FDA IDE Investigational Plan

LIVINGSTON, NJ--(Marketwired - August 19, 2015) - Milestone Scientific Inc.'s (NYSE MKT: MLSS) Epidural & Intra-Articular (IA) Subsidiary today announced successful results of the interim analysis of the COMPASS Study (CompuFlo® Assessment Study), a randomized, controlled, parallel group, multicenter, pivotal study to assess the safety and effectiveness of the epidural space verification with the CompuFlo® Epidural Computer Controlled System.

Milestone Scientific's Epidural & IA Subsidiary further announced the clinical trial for the epidural instrument has reached an enrollment of 200 patients. The goal of the pivotal IDE clinical trial is to demonstrate the accuracy of the CompuFlo technology in identifying and confirming the epidural space location.

Leonard Osser, Chief Executive Officer of Milestone Scientific, stated, "The interim analysis of the COMPASS Study clearly achieved the goal set by the FDA IDE Investigational Plan. We look forward to expeditiously continuing our enrollment and completing our trial later this year."

"With the U.S. epidural market estimated at over $7 billion annually and over 2.4 million women receiving epidurals, we believe this instrument will help reduce health risks to patients and malpractice risk to medical professionals administering epidurals," concluded Mr. Osser.

About Milestone Scientific Inc.

Milestone Scientific Inc. (MLSS) is a medical R&D company that designs, patents, incubates and commercializes a growing portfolio of innovative injection technologies. Milestone's computer-controlled systems make injections precise, efficient, and virtually painless. 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 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 for the year ended December 31, 2014. 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 Information

  • Contact:
    David Waldman or Klea Theoharis
    Crescendo Communications, LLC
    Email: mlss@crescendo-ir.com
    Tel: 212-671-1020