| The Board of Directors of Milestone Medical Inc. (WAR: MMD, the Issuer, the Company), today provided an update on its previously announced pivotal Investigational Device Exemption (IDE) clinical trial in the U.S. whose aim is to verify the placement of the epidural needle tip in the lumbar epidural space. The Company has also disclosed that three prominent university and pain management sites in the United States have received Ethical Committee (Institutional Review Board) approvals which enable the initiation of site enrollment. The clinical trial for the Issuer’s epidural instrument has reached an enrollment of 100 patients. The goal of the pivotal IDE clinical trial is to demonstrate the safety and efficacy of the epidural instrument. Chief Executive Officer of the Company reminded that the Issuer received clinical trial registration approval from the FDA just over a month ago, so the Board of Directors of the Issuer is pleased with the rate of enrollment in this relatively short time. The Company plans to enroll up to 400 patients in the trial at four separate sites in the U.S. Upon achieving full enrollment, the Company expects the clinical trial and accompanying statistical analysis to be completed in the third quarter of 2015, at which time the Issuer will return to the FDA for final market clearance. Legal basis: Section 3.1 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 | ||
| 2015-04-27 18:29:09 | Joseph D'Agostino | CFO |
