FDA marketing clearance granted for CompuFlo™ Epidural Instrument, adding global key opinion leaders, opening new markets and preparing Cosmetic Instrument for completion in 2018
LIVINGSTON, NJ–(Marketwired – December 20, 2017) – Milestone Scientific Inc. (NYSE: MLSS), a leading developer of computerized drug delivery instruments that provide painless and precise injections, today provided a year-end summary of news, chronicling the Company's key developments in 2017.
Leonard Osser, Interim Chief Executive Officer of Milestone Scientific, commented, “2017 marked a series of important accomplishments that we believe will set the stage for growth in 2018, such as U.S. Food & Drug Administration (FDA) marketing clearance of our CompuFlo® Epidural Instrument and earning the support of key opinion leaders (KOLs) in the U.S. and Europe, which will lead to opening up new markets around the world.”
2017 key highlights include:
- CompuFlo® Epidural Instrument received 510(k) marketing clearance from the FDA
- Clinical study showed the CompuFlo® Epidural Instrument correctly identified epidural space in 100% of labor and delivery patients
- Over 600 successful procedures completed in the U.S. using the CompuFlo® Epidural Instrument following regulatory marketing clearance
- Regulatory marketing clearance granted for the CompuFlo® Epidural Instrument in Australia and Saudi Arabia
- Announced planned completion of botulinum toxin (Botox, Dysport, Xeomin) Cosmetic Instrument in 2018
- Achieved solid growth in domestic dental sales
- Hospitals adopting The Wand® STA for pediatric dental injections and incorporating it into residency programs
“We appreciate the continued support of our shareholders, as we transition from a single-product company, to a diversified medical device company leveraging a robust platform technology. We have been successful in gaining marketing clearance and commencing the first phase leading up to the commercial launch of our first medical instrument, the CompuFlo™ Epidural Instrument. Following successful completion of the clinical trials, we are now gaining traction with KOLs for our Epidural Instrument. We expect to see the results of our trials published in leading industry journals in 2018, which should help drive market awareness and provide further validation.”
“Heading into 2018, we look forward to beginning the launch process of our Intra-Articular Instrument. In addition, we recently announced plans to launch our new Cosmetic Instrument for delivery of botulinum toxin (such as Botox® and Dysport®). There is a large and growing global market for botulinum toxin injections, with over 8.4 million botulinum toxin injections annually in the United States alone. The new Cosmetic Instrument is designed to inject accurate doses with the precision of a stylus pen. Moreover, most procedures are private pay and do not require reimbursement, which will help to further accelerate our commercialization timeline.”
“I am pleased to report that we are seeing domestic growth in our dental instruments and anticipate continued growth in 2018. We have been heavily focused on the European market and expect to resume sales growth in Europe in 2018. As a result, we expect our dental division will continue to generate positive cash flow on a standalone basis to help offset some of the costs related to launching our medical instruments. At the same time, we have maintained a solid balance sheet and clean capital structure, which we believe will help drive shareholder value as we execute on our strategy in 2018.”
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, 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.
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