Milestone Scientific Provides Update on CompuFlo® Epidural System Commercial Launch
News & Press
February 20, 2019 8:00 am
- Four published studies validate instrument effectiveness in identifying epidural space
- More than 1,500 epidural procedures performed by key opinion leaders
- First hospital in Italy adopts CompuFlo for all epidurals in labor and delivery
- Eight new distributors added in the U.S. to expand sales network
- Peripheral nerve block patent secured
LIVINGSTON, N.J., Feb. 20, 2019 — Milestone Scientific Inc. (NYSE: MLSS) today reported momentum in the first phase of the commercial roll-out of its CompuFlo® Epidural System. CompuFlo is an instrument that helps anesthesiologists objectively identify the epidural space with 99% success on the first attempt. Easier, more reliable identification is essential to reducing costs, failed epidurals and complications.
Over the course of eight months, three major anesthesia journals published positive results of four CompuFlo clinical studies. Anesthesia & Analgesia, Anesthesiology Research & Practice and the International Journal of Obstetric Anesthesia all featured studies that found CompuFlo consistently differentiates false loss of resistance from true loss of resistance during epidural placement. Confidence in recognizing a true loss of resistance can help improve the efficacy of anesthesia, reduce complications, and speed the procedure learning curve for trainees.
Kent Krafft, Vice President of Clinical Technology Inc. (CTI), a leading specialty distributor of medical products in the mid-western region of the United States, commented, “The peer-reviewed, published studies offer independent evidence that will be an asset to CTI as we educate providers on the benefits of objective, quantifiable and real-time confirmation of accessing the epidural space. This data echoes the positive trial feedback we’re receiving from top anesthesiologists and will help build a new standard of care in labor and delivery with use of the CompuFlo Epidural instrument.”
CTI is one of eight new distributors added to Milestone Scientific’s decentralized sales network that covers key markets in the U.S. and across Europe. All have been actively engaged in product demos and trials within hospitals and clinics, as well as medical training programs.
Milestone Scientific recently announced Ospedale “Pugliese Ciaccio” di Catanzaro is the first hospital in Italy to use CompuFlo for all epidurals in labor and delivery. The instrument was selected for its real-time, objective verification that can help reduce failure rates, which require further treatment and interventions.
Leonard Osser, Interim Chief Executive Officer of Milestone Scientific, commented, “Through these peer-reviewed studies and hands on demonstrations, anesthesia providers are recognizing they now have a proven alternative to the loss-of-resistance syringe. More than 1,500 epidural procedures have been performed by key opinion leaders, who report the Dynamic Pressure Sensing technology® in CompuFlo can build physician and resident confidence. I am pleased with its momentum in the market and our sales and market strategy is poised to accelerate CompuFlo’s adoption as the new standard of care.”
Milestone Scientific also received Notice of Allowance for a key patent from the U.S. Patent and Trademark Office this past November. The patent covers the method and apparatus for performing a peripheral nerve block (PNB). This patent will further expand Milestone Scientific’s intellectual property portfolio by leveraging the Company’s proprietary Dynamic Pressure Sensing technology to develop an instrument that will allow medical professionals to precisely control the numerous critical parameters of performing a PNB procedure to improve safety, efficiency and efficacy.
About Milestone Scientific Inc
Milestone Scientific Inc. (MLSS) is a medical device 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, 2017. 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.
David Waldman or Natalya Rudman
Crescendo Communications, LLC