Milestone 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.”
