MILESTONE (MMD): The submission of 510(k) Application for Marketing Clearance of the Epidural Instrument and Disposables in the United States - raport 7

Raport bieżący nr 7/2016

Podstawa Prawna:
Art. 17 ust. 1 MAR - informacje poufne.

The Board of Directors of Milestone Medical Inc. (WAR: MMD, “the Company”, “the Issuer”) today announced it has filed its 510(k) application with the U.S. Food & Drug Administration (FDA) for marketing clearance of its epidural instrument and disposables in the United States.

As previously announced, the Company 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 Investigational Device Exemption (IDE) clinical trial was to demonstrate the accuracy of the CompuFlo technology in identifying and confirming the epidural space location.

The Company also announced plans to submit the final data from the COMPASS Study including the results of the labor and delivery arm to a leading industry journal for publication. Interim data from the pain management arm of the study was 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 on May 28-30th.

The Board of Directors is pleased to submit the 510(k) application on the heels of completing the clinical trials in the United States. Having completed these trials, the Company is now accelerating the efforts to enter into domestic and international distribution agreements in advance of FDA marketing clearance. The study was designed to support not only submission to the FDA, but also facilitate U.S. reimbursement submissions as well as worldwide marketing.