Milestone Scientific (NYSE:MLSS) said today that its CompuFlo epidural computer-controlled anesthesia system won 510(k) clearance from the FDA.
The Livingston, N.J.-based company’s CompuFlo Epidural instrument uses dynamic pressure sensing to help anesthesiologists correctly identify the epidural space and significantly reduce complications in real-time, according to Milestone.
Shares in the company jumped up 18% today, trading at $1.71 in mid-afternoon activity.
“We are delighted to receive marketing clearance from the FDA, which is considered globally to be the regulatory gold standard in premarket review,” CEO Leonard Osser said in prepared remarks. “I would like to thank all the employees, advisors, key-opinion leaders (KOL) and other stakeholders that were instrumental in helping us to achieve this major milestone.”
“Looking ahead, we are now focused on reaching out to the top KOLs in the U.S., as we have been doing successfully across Europe. The CompuFlo Epidural System’s ease of use allows use by medical professionals with varying levels of experience, which further drives the value proposition of this technology. In addition, due to what we see as the device’s add-on value proposition, we plan to seek reimbursement codes over and above those already in place for traditional epidural procedures.”
The regulatory win was supported by the company’s pivotal Compass study, which evaluated the safety and effectiveness of the instrument’s epidural space verification.
The primary objective of the 400-patient trial was to determine if the success rate of performance of lumbar epidural anesthesia with the CompuFlo Epidural is equivalent to performance of the same procedure with the LOR technique.
Using the CompuFlo system, anesthesiologists objectively identified the epidural space with 99% success on the 1st attempt, Milestone reported.
