B-Temia Asia obtains Taiwan Food & Drug Administration (TFDA) product license
B-Temia gains commercial access to the Taiwanese market
QUÉBEC CITY, Sept. 21, 2020 /PRNewswire/ - B-Temia Asia, a joint venture company between Wistron Medical Technology Company and B-Temia Inc. (the "Company") incorporated in November 2019, announces today that it obtained the Taiwanese Food and Drug Administration (TFDA) product license for its powered human mobility device "KeeogoTM. This license opens a new market and allows the Company to commercialize KeeogoTM in Taiwan, which represents one of the most important markets of the Asian territory. Last week, B-Temia Inc. obtained its 510(k) Clearance from the American Food and Drug Administration (FDA) as well as the CE Mark in December last year.
"The work we have accomplished for the last two years to prepare and obtain new regulatory approvals, such as the CE Mark and 510(k), paved the way to this achievement. This is another major milestone for B-Temia Asia as this new market will be added to the previously approved markets such as Singapore, Hong Kong, Japan and Malaysia", explains Stéphane 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. Therefore, it gives us great confidence for the other regulatory approvals we are currently completing for additional territories", added Mr. Bédard.
Alexandre Jokic, Vice President Regulatory and Clinical Affairs, states, "We are pleased to confirm that the Taiwanese market is now open for people who suffer from a stroke. The immediate clinical benefits of KeeogoTM were effectively proven on this targeted population. In addition, KeeogoTM was cleared as a personal assistive device for home use and will provide the clinicians and patients with the versatility they need to gain more freedom in their rehabilitation program or daily living activities. It is also worth mentioning that the results of the most recent clinical trials were very well received by the Taiwanese authorities".
KeeogoTM, short for "Keep on going", is a powered mobility device for lower limbs developed by B-Temia. Based on the B-Temia's proprietary DermoskeletonTM technology, KeeogoTM is a lightweight exoskeleton that detects, responds and supports an individual's movements with advanced software and motorized assistance, providing a true human- machine interface based on the individual needs. KeeogoTM 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). For more information, visit our web site 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.
About B-Temia Asia
Established in September 2019, B-Temia Asia is a joint venture company between Wistron Medical Technology Company and B-Temia Inc, dedicated to the commercialization of B-Temia's medical products on the Asian territory. Since its foundation, B-Temia Asia operates in Taiwan, China, Hong Kong, Japan, Malaysia, Thailand, Korea and Singapore.
About Wistron Corporation
Wistron Corporation is among the world's largest companies producing products such as servers and storage devices for cloud computing and data centers, enterprise and consumer desktop and laptop PCs, smartphones, rugged industrial devices and control units, medical devices and big data analytics, smart home and smart retail IoT products, AR/VR, green recycling, etc. Wistron's full array of engineering teams allows Wistron's customers to outsource some or all of their product development and manufacturing tasks to focus on their core competence and further develop intellectual properties. Wistron manufactures medical products for medical industry customers in two ISO 13485 certified factories, located in the Hsinchu Science Park in Taiwan and in Chongqing, China. For more information, please visit: www.wistron.com.