• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

Milestone Scientific lands marketing clearance in Saudi Arabia, Australia

April 19, 2017 By Sarah Faulkner

Milestone ScientificMilestone Scientific (NYSE:MLSS) shares rose today after the company said it won marketing clearance in Saudi Arabia, weeks after winning a regulatory nod in Australia for its epidural and intra-articular instruments.

The company’s CompuFlo Epidural instrument uses dynamic pressure sensing to help anesthesiologists correctly identify the epidural space and significantly reduce complications, according to Milestone. The CompuFlo Intra-Articular instrument also features dynamic pressure sensing for precise computerized drug injections into intra-articular joint spaces for patients with osteoarthritis.

MLSS shares were trading at $1.40 apiece in afternoon activity today, up 4%.

Earlier this month, Milestone reported its results for the fiscal year ending Dec. 31, 2016.

The Livingston, N.J.-based company reeled in its losses to -$5.9 million, or -22¢ per share, on sales of $10.5 million, for bottom-line growth of 7.3% on sales growth of 10.5% compared with the same period last year.

“We believe we are still on track to receive regulatory marketing clearance in the U.S. for our epidural instrument in the first half of 2017,” CEO Leonard Osser said in prepared remarks. “In 2016, we began the transition of our medical subsidiary from a product development company to our current focus on commercialization, pending FDA marketing clearance. Importantly, we completed clinical testing of our epidural instrument and, despite the added cost, we scaled up the trial to support our reimbursement strategy and global marketing initiatives. In advance of FDA marketing clearance, we have been cultivating relationships with distributors and key opinion leaders in both the U.S. and internationally, including Europe and Asia as well as the Middle East and North Africa. We have also resubmitted our application to the FDA for our intra-articular instrument, and we are confident that equivalency will be demonstrated based on the results of the new human factors study as well as the fact our dental instrument has been used successfully in over 60 million injections to date.

“We completed a public offering in December yielding gross proceeds of $3 million, which will allow us to accelerate sales and marketing activities related to the planned launch of our epidural instrument. We believe this capital raise will be sufficient to support the execution of our growth strategy for the foreseeable future. We continue to generate positive cash flow within our dental subsidiary, and with the completion of our clinical trials for the epidural instrument, we expect that the burn rate of our medical subsidiary will be further reduced.”

Filed Under: Drug-Device Combinations, Featured, MassDevice Earnings Roundup, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: milestonescientific

IN CASE YOU MISSED IT

  • Tandem Diabetes Care wins CE mark for Mobi insulin pump with Control-IQ+ technology
  • Glooko adds chief strategy officer to chief medical officer’s title
  • Cordis launches 10,000-patient registry for drug-eluting balloon
  • Senseonics opens $50M public offering, $25M private placement with Abbott
  • Study links Abbott CGM use to lower risk of hospitalizations due to heart complications

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy | RSS