QUÉBEC CITY, Dec. 10, 2019 /CNW Telbec/ - B-Temia Inc. (the "Company"), a Canadian robotics tech company and leader in the human mobility market, announces today that it is now authorized by the notified body British Standard Institute (BSI) to affix the CE marking on its powered human mobility device Keeogo™. The CE marking opens new markets and allows the Company to commercialize Keeogo in the 28 European Union countries and facilitates its registration in some countries in Asia.
"This is good news for us and our customers. After years working on profiling the efficacy and the safety of its hyper-innovative technology, B-Temia now has clearance to sell Keeogo on the European territory and the ability to accelerate regulatory authorizations processes in many other countries that recognize the CE marking", explains Stephane Bédard, President and Chief Executive Officer of the Company. "This endorsement is one of the key milestones of our global expansion plan initiated in 2017 with our Asia-based partner Wistron Corp, and therefore, it gives us great confidence for the other regulatory approvals we are currently completing for additional territories", adds Mr. Bedard.
Alexandre Jokic, Vice President Regulatory Affairs, mentions that "The indication for use approved by the authority is the broadest and the most versatile on the exoskeleton market, prescribing that Keeogo is indicated to assist users with musculoskeletal weaknesses or lower limb instability and provides them with strength and stability to assist their ambulatory activities both in clinics and at home (e.g.: walking, ascending and descending stairs, exercising and carrying out daily activities)" for which this indication for use provides the commercial versatility required for such market.
About Keeogo™ Keeogo™ is a lower limb powered human mobility device developed by B-Temia. Its proprietary DermoskeletonTM technology is a novel type of lightweight exoskeleton that provides a true human-machine interface. It detects, responds and then supports an individual's movements with advanced software and motorized assistance. Keeogo, short for "Keep on going", has benefited those with knee osteoarthritis, muscular or neuro-degenerative conditions, spinal cord or brain injury and other injuries affecting mobility. Keeogo™ is used as rehabilitation equipment in clinics or as a personal assistive device at home, work and in the community to aid with daily activities. Keeogo™ is commercially available in Canada and is CE marked. For more information, please visit: www.keeogo.com.
About B-Temia Inc. Founded in 2010, B-Temia is an innovative Canadian robotics tech company that develops and markets cutting-edge products for the growing market of human augmentation systems. B-Temia operates through a global network of companies, including B-Temia Inc., B-Temia Asia and B-Temia USA Inc., in the medical, industrial and military fields. B-Temia owns a patented technology called Dermoskeleton™ that restores, maintains or enhances the mobility of users. For more information, please visit: www.b-temia.com.
Note: Keeogo™ is not cleared by the Food and Drug Administration in the United States.