B-TEMIA INITIATES PIVOTAL CLINICAL TRIAL TO SUPPORT COMMERCIAL LAUNCH OF KEEOGO™ IN THE U.S.
Partnering with three of the most reputable rehab centers in North America
Quebec, November 23, 2015 – B-TEMIA Inc., the market leader in human augmentation, today announced that it has initiated a multi-centre pivotal clinical trial, aimed at demonstrating the superior clinical benefits and safety for home use of its powered assistive Dermoskeleton™ technology, called Keeogo™, for patients suffering from reduced mobility due to their medical conditions. Led by Principal Investigator, Dr. Chris A. McGibbon, PhD, from the University of New Brunswick’s, Faculty of Kinesiology and Institute of Biomedical Engineering, the study is expected to generate the required data to support the submission of a 510(k) pre-market notification to the U.S. Food and Drug Administration in 2016, a prerequisite to start commercialization in the United States.
