New device for lower extremity rehabilitation receives FDA approval!

COTRAS Co., Ltd. (hereon referred to as COTRAS), an innovative medical-device firm focused on rehabilitation products, has secured approval from the U.S. Food and Drug Administration (FDA) for MOBILISE, a medical device to help degenerative knee arthritis patients.

MOBILISE has been promoted among UNIST (Professor Sang Hoon Kang), COTRAS Co., Ltd. (hereon referred to as COTRAS), Korea Institute of Science and Technology (KIST), and Seoul National University Bundang Hospital (SNUH). The aim is to further develop the original technology created by UNIST and KIST into marketable products for the benefit of the public with the support of healthcare professionals at SNUH. As a result, COTRAS Co., Ltd. succeeded in developing and commercializing their new medical device for lower extremity rehabilitation, and thus earning the FDA approval in two years, which was shorter than usual.

As part of the collaborations among industry, university, research institute, and hospital, UNIST, COTRAS, KIST, and SNUH have carried out collaborative research under the governmental support of the Korea Medical Device Development Fund (KMDF) since September 2020. Their performance has been recognized as an outstanding performance and regarded as an exemplary case, which demonstrates the importance and significance of medical science and engineering research, spanning medicine, biomedical science and engineering.

In 2018, Korea joined the ranks of the aging society in which persons aged 65 and above account for more than 14.4% of the entire population, and thus is expected to become a ‘super-aged society’ in 2025. An estimated 37.3% of people over 50 years and 38.1% of people aged 65 and over have some level of joint pain or arthritis. This may also lead to severe arthritis cases, such as a chronic, degenerative joint disease. As of 2018, the number of patients who had undergone artificial joint replacement amounts to approximately 9.4 million. About 15% of the elderly population aged 65 or more suffer from sarcopenia, which is a risk-factor for all-cause mortality due to a decreased walking ability and decline in physical functioning and this number is expected to increase due to population ageing.

MOBILISE is an aging-friendly device that provides customized step-by-step training according to the level of reduction in lower-limb muscle function. It aims to provide a personalized physical rehabilitation training system for the next generation of silver care, which differentiates itself from the existing rehabilitation devices that focus on muscle strengthening. The goal is to support aging-in-place by providing customized geriatric rehabilitation to help the elderly regain mobility and function, while spending their healthy years in their homes.

The new device, which is relatively simple to use, aids in improved muscle strength through eccentric muscle contraction, audiovisual muscle power training, lower extremity pivot, and real-time knee internal moment biofeedback. It will generate excitement among users, as it uses the user interface (UI) used in real-time virtual reality (VR) games, and thus capable of assessing motor function and balance, which are essential for lower limb rehabilitation. It is also equipped with cutting-edge new technologies such as real-time knee internal moment biofeedback, marker augmented reality (AR) lower limb posture biofeedback, and intrinsic acceptance sensory evaluation.

Meanwhile, the FDA has formally approved MOBILISE as a Class II medical device. This shows that the new device has met the FDA-identified performance criteria, and thus demonstrates that it is as safe and effective as a legally marketed device. With this approval, there is a keen interest on making full-fledged entry into the Korean market, as well as overseas markets.