Milestone Scientific’s (OTC:MLSS) epidural & intra-articular subsidiary said today that the investigative device exemption trial of its CompuFlo epidural computer controlled system has returned successful interim results.
The Compass trial is designed to asses the safety and effectiveness of the epidural space verification of CompuFlow, which identifies and confirms epidural space locations, Livingston, N.J.-based Milestone Scientific said.
The company said the pivotal IDE study has enrolled 200 patients to date.
“The interim analysis of the Compass study clearly achieved the goal set by the FDA IDE investigational plan. We look forward to expeditiously continuing our enrollment and completing our trial later this year. With the U.S. epidural market estimated at over $7 billion annually and over 2.4 million women receiving epidurals, we believe this instrument will help reduce health risks to patients and malpractice risk to medical professionals administering epidurals,” CEO Leonard Osser said in a press release.
In September last year, Milestone Scientific took a major hit after announcing that its recently formed joint venture Milestone Ophthalmic Sp. z o.o. (MOSZ) would merge with Emmerson Wierzytelnosci Hipoteczne S.A. (EWH).