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LIVINGSTON, NJ --(Marketwired - August 08, 2017) - Milestone Scientific Inc.
(NYSE MKT: MLSS) a medical R&D company that designs, patents, incubates and commercializes a growing portfolio of innovative injection technologies, today announced that the first patient in the U.S was treated with the CompuFlo®
Epidural Instrument at the University of Miami Hospital, following Milestone Scientific's receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) on June 9, 2017. The CompuFlo®
Epidural Instrument provides anesthesiologists and medical practitioners, for the first time, with the unique ability to objectively identify and confirm the epidural space.
"We are excited to offer a new, innovative technology to objectively identify and confirm the epidural space, which is a critical step for successful and safe epidural anesthesia. For the first time, we are also able to document successful epidural space identification in the patient's record in a reviewable manner, which represents an important advancement regarding quality control," said Ralf Gebhard, M.D., a key opinion leader (KOL) in Acute Pain Management and Regional Anesthesia and a Professor in the Department of Anesthesiology, Perioperative Medicine and Pain Management at the University of Miami. Dr. Gebhard is also the Chief of the Division of Acute Pain Management and Regional Anesthesia and serves as Associate Vice Chairman for Clinical Research. Dr. Gebhard is a member of Milestone Scientific's Scientific Advisory Board.
Mark Hochman, D.D.S., Director of Clinical Affairs for Milestone Scientific commented, "This is a highly anticipated event in the history of the Company. We are extremely pleased to bring our innovative technology to physicians and patients in the U.S., where we believe it may make a significant difference in improving healthcare outcomes. Not only is this an important milestone in the commercial rollout out of our CompuFlo® Epidural Instrument, but it represents the first of many planned medical applications in our product development pipeline."
The Company also reported that the CompuFlo® Epidural Instrument was featured on ABC's Miami affiliate, WPLG-TV, including an interview of Mark Hochman, D.D.S., and Ralf Gebhard, M.D.
The clinical benefits of CompuFlo®
are documented in the COMPASS Study (CompuFlo®
Assessment Study), which was a prospective, randomized, controlled, parallel group, multicenter, pivotal study to assess the safety and effectiveness of epidural space verification with the CompuFlo®
Epidural Instrument. The primary objective of the COMPASS study was to determine whether the success rate of performance of lumbar epidural anesthesia with the CompuFlo Epidural to identify the epidural space is equivalent to performance of lumbar epidural anesthesia with the LOR technique. The clinical study enrolled 400 patients, of which two-hundred-forty subjects (240) required epidural procedure as part of the chronic pain management and one-hundred-sixty (160) required epidural procedure for acute pain management during labor and delivery. The overall results of the COMPASS study demonstrated that the CompuFlo®
Epidural can serve as an everyday epidural needle placement confirmation solution.
About Milestone Scientific Inc.
Milestone Scientific Inc. (MLSS) is a leading medical research and development company that designs and patents innovative injection technologies. Milestone's computer-controlled systems are designed to 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, market acceptance of its products, 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, 2016. 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.
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...