SOURCE: Milestone Scientific, Inc.

Milestone Scientific

November 04, 2015 13:02 ET

Milestone Scientific's Epidural & Intra-Articular Subsidiary Milestone Medical Inc. Submits Initial Results of Clinical Trial Using CompuFlo® Epidural Instrument on Obese Patients to Prestigious Pain Management Society for Publication

CompuFlo Technology Objectively and Accurately Identifies the Epidural Space in Obese Patients When Compared to Radiological X-Ray Based Fluoroscopy

LIVINGSTON, NJ--(Marketwired - November 04, 2015) - Milestone Scientific Inc.'s (NYSE MKT: MLSS) Epidural & Intra-Articular (IA) Subsidiary today announced that it has submitted initial results of the prospective, open label, clinical trial assessing the CompuFlo® technology in correctly identifying the epidural space during an epidural procedure in obese patients to a prestigious American pain management society in advance of this organization's annual meeting in 2016.

Success of the epidural technique depends upon the correct identification of the epidural space. The incidence of difficult epidural catheter placement and early failure is significantly more likely among the morbidly obese population. The increased amount of subcutaneous and epidural fat in the obese population can pose a significant challenge to successful epidural catheter placement.

After IRB approval and under United States Food and Drug Administration Investigations Device Exemption, patients were enrolled in a prospective controlled multi-center trial and were randomized to have the epidural space identified by either standard of care methods utilizing the loss of resistance technique or by utilizing real-time pressure measurement at the epidural needle tip via the CompuFlo® Epidural Instrument. A blinded independent observer evaluated correct identification of the epidural space defined as correct spread of dye demonstrated by fluoroscopy.

Leonard Osser, Chief Executive Officer of Milestone Scientific, added, "This second submission focusing on morbidly obese patients follows our earlier submission focusing on a broader patient population. Moreover, unlike procedures utilizing fluoroscopy, CompuFlo® has the added potential benefit of avoiding patient exposure to radiation without compromising procedure safety or efficacy."

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