Milestone Scientific‘s (OTC:MLSS) said today it completed the pivotal study of its CompuFlo epidural computer controlled system, investigating the safety and efficacy of the epidural space verification of the system.
The 400-patient, multicenter pivotal Compass study looked to compare treatment with the CompuFlo device against the current standard of care for patients undergoing pain management and those undergoing child labor or delivery.
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, Milestone Scientific said.
“We are pleased to have completed this important trial and look forward to submitting the study results to the FDA. Interim pain-management data has been presented in the U.S. at the American Society of Regional Anesthesia and Pain Management, and American Pain Society annual meetings. Additional interim data from the pain management arm was recently presented at the European Society of Anesthesiology annual meeting in London May 28-30th. It is important to note, this study was designed to support not only submission to the FDA, but also facilitate U.S. reimbursement submissions as well as worldwide marketing,” CEO Leonard Osser said in a press release.
The goal of the trial is to demonstrate the efficacy of the CompuFlo device for identifying and confirming epidural space location. The company said it plans to “finalize the statistical analysis” and complete its FDA submission in the “very near future.”
Last month, MIlestone said it approved a follow-on round of financing, expecting to bring in between $1.7 and $2 million.
Funds in the follow-on round will come from the private placement of unregistered common stock at $2 per share from investors who participated in the company’s 2014 financing round, the Livingston, N.J.-based company said.
Last August, Milestone’s epidural & intra-articular subsidiary said the investigative device exemption trial of its CompuFlo epidural computer controlled system has returned successful interim results.