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.
“This is the first international clinical trial involving the Dermoskeleton™ technology that aims at demonstrating the efficacy and safety of Keeogo™ during everyday community and home mobility use, something that has not been possible in the past with other exoskeleton technologies that were developed principally for use in a clinical rehabilitation setting,” stated Dr. Chris A. McGibbon.
As part of the trial, B-TEMIA has partnered with three of the most reputable rehabilitation institutions in North America: the Rehabilitation Institute of Chicago, the Spaulding Rehabilitation Hospital Boston, and the Toronto Rehabilitation Institute–UHN.
“This pivotal clinical trial will be key in supporting the commercial launch of Keeogo™ in the U.S. market. Based on earlier very positive pilot studies, we are confident that it will demonstrate how Keeogo™ could significantly improve the daily activities of those who suffer from disabilities that impact their mobility,” said Mr. Stéphane Bédard, President & CEO of B-TEMIA.
Keeogo™ is a powered assistive walking device and is the first product incorporating the Dermoskeleton™ technology developed by B-Temia. Keeogo™ has been used by individuals with medical conditions such as osteoarthritis of the knee, multiple sclerosis, Parkinson’s disease, and other conditions that impact mobility. Keeogo™ is already commercially available for rental or purchase in Canada. It is not yet available in the United States.
About B-TEMIA Inc.
B-TEMIA Inc. is a medical device manufacturer that develops and markets products in the growing market of human augmentation systems. B-TEMIA operates through two wholly-owned subsidiaries, B-TEMIA Health Inc. and B-TEMIA Military Inc. B-TEMIA owns a patent-pending wearable Dermoskeleton™ technology that restores, maintains or enhances the mobility of users.
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