SOURCE: Milestone Scientific Inc.

Milestone Scientific

April 21, 2015 07:30 ET

Milestone Scientific Provides Update on U.S. Clinical Trials for Epidural Instrument

Epidural & IA Subsidiary Has Commenced Pivotal IDE Clinical Trial in the U.S. With the Aim of Confirming Epidural Space Location; Three Prominent University and Pain Management Sites in the Unites States Have Received Institutional Review Board Approvals; Pivotal Clinical Trial Reaches Important Milestone of 100 Patients Enrolled

LIVINGSTON, NJ--(Marketwired - April 21, 2015) - Milestone Scientific Inc. (OTCQB: MLSS), a medical R&D company that designs, patents, incubates and commercializes a growing portfolio of innovative injection technologies, today provided an update on its Epidural & IA Subsidiary, which, as previously announced, has commenced its pivotal Investigational Device Exemption (IDE) clinical trial in the U.S. with the aim of verifying the placement of the epidural needle tip in the lumbar epidural space, and that three prominent university and pain management sites in the United States have received Institutional Review Board approvals. The company further announced the clinical trial for the company's epidural instrument has reached an enrollment of 100 patients. The goal of the pivotal IDE clinical trial is to demonstrate the safety and efficacy of the epidural instrument. 

Leonard Osser, Chief Executive Officer of Milestone Scientific, stated, "With our Epidural & IA Subsidiary receiving clinical trial registration approval from the FDA just over a month ago, we are pleased with the rate of enrollment in this relatively short time. Our Epidural & IA Subsidiary plans to enroll up to 400 patients in the trial at four separate sites in the U.S. Upon achieving full enrollment, we expect the clinical trial and accompanying statistical analysis to be completed in the third quarter of 2015, at which time the Epidural & IA Subsidiary will return to the FDA for final market clearance. 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."

About Milestone Scientific Inc.

Milestone Scientific Inc. (MLSS) is a leading medical research and development company that designs and patents innovative injection technology. 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, 2013. 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