B-Temia Inc. Obtains 510(k) Clearance for Keeogo from the USA Food & Drug Administration (FDA)
QUÉBEC CITY, Sept. 14, 2020 /PRNewswire/ - B-TEMIA Inc. (the "Company") announces that it received 510(k) clearance from the US regulator for the commercialization of its powered human mobility device KeeogoTM Dermoskeleton System in the United States of America. 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. KeeogoTM is a true disruptive product, with no comparable around the world, which made the alignment with the FDA challenging. This US market clearance is the biggest milestone of our global regulatory expansion, as the 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 recognized our clinical trial strategy that demonstrates the clinical benefits and the immediate effect on gait quality for stroke patients and agreed on the demonstration of the safety and effectiveness of the KeeogoTM DermoskeletonTM system. KeeogoTM has been cleared for stroke patients having gait deficits and is intended to provide mobility assistance to the user in rehabilitation settings under the supervision of a trained healthcare professional for this population". Mr. Jokic adds, "We were appreciative of the work accomplished by all collaborators from all over the world, who 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."
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