| The Board of Directors of Milestone Medical Inc. (WAR: MMD, “the Company”, “the Issuer”), today announced it has completed its COMPASS Study (CompuFlo® Assessment Study), a randomized, controlled, parallel group, multicenter, pivotal study to assess the safety and effectiveness of the epidural space verification with the CompuFlo® Epidural Computer Controlled System. The clinical trial for the epidural instrument reached an enrollment of 400 patients and consisted of two separate arms: (i) pain management; and (ii) labor and delivery. Both arms were compared against the current medical standards of care. The goal of the pivotal IDE clinical trial was to demonstrate the accuracy of the CompuFlo® technology in identifying and confirming the epidural space location. The Company plans to finalize the statistical analysis and otherwise complete its submission of the COMPASS study to FDA in the very near future. The Board of Directors of the Issuer is 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. Legal basis: § 3 subparagraph 1 of the Exhibit 3 to the Alternative Trading System Rules “Current and Periodical Information in the Alternative Trading System on the NewConnect Market". |
| Data | Imię i Nazwisko | Stanowisko | Podpis | ||
| 2016-06-07 11:15:25 | Joseph D'Agostino | Chief Financial Officer |
