The Board of Management of Milestone Medical Inc. (WAR: MMD, the “Company”, the “Issuer) today announced the start of its pivotal clinical trial for its epidural instrument at a major pain management center in the United States. The Company has also met FDAAA 801 requirements for submission of the clinical trial information to the Director of the National Institutes of Health (NIH) for inclusion in the registry and results database established via ClinicalTrials.gov for its CompuFlo Epidural Computer Controlled System for assessing the safety and effectiveness of the instrument for identifying the epidural space. Recruitment for the clinical trial is underway and the first patients are now taking part in the study.
The Company appreciates the support and cooperation it has received from one of the most advanced and best equipped pain management centers in United States. This clinic has some of the leading board certified physicians, as well as a large number of existing patients suffering a variety of complications requiring epidurals. The Issuer believes its epidural instrument has the potential to help improve the treatment of chronic pains, while improving safety of the injection for the patient and reducing malpractice risk for the medical practitioner. Clinical trials will serve as an important step forward and validation of the Company’s pressure sensing injection technology in the U.S. Upon completion of the clinical trials, the Issuer will then conduct a statistical analysis of the studies, at which time it plans to return to the FDA for final marketing clearance for the Company’s epidural instrument.
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”.
Osoby reprezentujące spółkę:
Joseph D'Agostino - CFO