B-TEMIA INC. OBTAINS 510(K) CLEARANCE FOR KEEOGO™ FROM THE USA FOOD & DRUG ADMINISTRATION (FDA)
Québec City, QC, September 14, 2020 – B-Temia Inc. (the “Company”) announces that it received 510(k) clearance from the United States Food and Drug Administration for its powered human mobility device Keeogo™ Dermoskeleton System. This clearance opens the largest medical device market in the world.
Stéphane Bédard, Chief Executive Officer of B-Temia, says “The work we have accomplished since 2019 paved the way to this achievement. This is a major milestone for B-Temia. I am tremendously proud of our team since they were able to manage many challenges during the process to ensure that we reach our corporate objective. This US market clearance is the biggest milestone of our global regulatory expansion, asthe USA is the largest medical device market. It also gives us great confidence for the other regulatory approvals we are currently completing for additional territories”. Mr. Bédard adds “B-Temia was created to allow people to regain their autonomy in mobility. This US clearance for stroke patients is a perfect example of the achievement of our mission.”
Alexandre Jokic, Vice President Regulatory and Clinical Affairs, mentions, “We are pleased to confirm that the US FDA cleared the Keeogo to help assist ambulatory functions in stroke patients with gait deficits. The 510(k) submission was supported by a clinical study demonstrating an improvement in gait quality when wearing the device as well as patient and clinician safety. Keeogo™ is intended for use in rehabilitation settings under the supervision of a trained healthcare professional”. Mr. Jokic adds, “We were appreciative of the work accomplished by all collaborators from all over the world, whom we would like to thank, and the work done with the US regulator that allowed us to provide them all the necessary information to avoid any delay during the review process.”
Keeogo™, short for “Keep on going”, is a lower limb powered human mobility device developed by B-Temia. Its proprietary Dermoskeleton™ technology is 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™ is a robotic exoskeleton intended to provide mobility assistance to the user based on their individual needs. It is a medical device that provides complementary knee strength and movement cues to assist trained healthcare professionals in rehabilitation and training of walking gait, sit-to-stand and stand-to-sit, squatting and stair climbing (ascent and descent). In the United States, Keeogo™ is cleared for use in rehabilitation settings under supervision of a trained healthcare professional to help assist ambulatory function in stroke patients with gait deficits who meet the user assessment criteria. Keeogo™ is not intended for sports. For more information, visit our web site
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, visit: www.b-temia.com.