Rehabilitation Medical Device KOTRAS 'Mobilize' Receives US FDA Class II Approval... Achieves Early Commercialization

KOTRA's 'MOBILISE' machine.

[Asia Economy Yeongnam Reporting Headquarters Reporter Hwang Dooyul] IT rehabilitation medical device innovation company Cotras' ‘MOBILISE’ has received medical device approval from the U.S. Food and Drug Administration (FDA).

MOBILISE is a research project that achieved early commercialization by utilizing rehabilitation engineering core technologies from UNIST and the government-funded research institute KIST, with professional medical advice and clinical support from Bundang Seoul National University Hospital.

Cotras successfully completed and commercialized the device as a lower limb rehabilitation medical device that can be sold in the U.S. in an exceptionally short period of about two years, which is much shorter than the average.

MOBILISE is the result of industry-academia-research-hospital collaborative research conducted since September 2020 by Bundang Seoul National University Hospital, Cotras, KIST, and UNIST, supported by the national project under the Pan-Government Full-Cycle Medical Device R&D Project Group, and was selected as an excellent achievement of the project group.

South Korea entered an ‘aged society’ in 2018, with the proportion of elderly people aged 65 or older reaching 14.4% of the population, and it is expected to become a ‘super-aged society’ exceeding 20% by 2025.

Among those aged 50 and older, 37.3%, and among those aged 65 and older, 38.1% suffer from knee osteoarthritis, which causes knee joint pain and can lead to disability in severe cases. The number of patients undergoing knee arthroplasty due to knee osteoarthritis reached 94,000 in 2018.

Sarcopenia, which affects survival rates due to decreased walking ability and physical function decline, affects about 15% of the population aged 65 and older, with even more people estimated to be at risk.

MOBILISE is an elderly-friendly device that provides customized, stepwise training according to the pattern of lower limb muscle function decline in patients with sarcopenia and degenerative knee osteoarthritis.

The device is differentiated from existing rehabilitation devices that focus solely on muscle strengthening by offering functions for assisting diagnosis of lower limb muscle function in the elderly and evaluating rehabilitation effects.

It also provides a next-generation silver care model with practical effectiveness by enabling elderly individuals to perform customized rehabilitation training while aging in place at home or in the community.

The device offers eccentric muscle contraction for muscle strengthening, audiovisual muscle power training, and lower limb pivoting training for lower limb function decline, and it can perform neuro-muscular control training through real-time knee adduction moment biofeedback.

Using a virtual reality game interface to stimulate interest, the device is relatively easy to use. It also allows evaluation of balance ability and motor function before and after training, which are essential for lower limb rehabilitation.

Advanced new technologies such as real-time knee adduction moment biofeedback, markerless augmented reality (AR) lower limb posture biofeedback, and proprioception evaluation are also incorporated.

Cotras’ ‘MOBILISE’ has been approved as a Class II medical device by the U.S. FDA. This means it is a medical device that can be sold in the U.S. and has been confirmed for effectiveness and safety.

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