Approval of Confirmatory Clinical Trial Plan for EverX's Musculoskeletal DTx 'MoraCure'

EverX announced on the 22nd that its musculoskeletal rehabilitation exercise digital therapeutic device (DTx), Mora Cure, received approval from the Ministry of Food and Drug Safety on the 19th for a confirmatory clinical trial for patellofemoral pain syndrome (PFPS). This is described as the first confirmatory clinical approval for PFPS treatment among musculoskeletal DTx.

EverX's musculoskeletal digital therapeutic device (DTx) 'Mora Cure'
Photo by EverX

Mora Cure is a multidisciplinary DTx that combines rehabilitation exercise therapy and cognitive behavioral therapy (CBT). Following the previous exploratory clinical trial, the current confirmatory trial plans to evaluate the safety and efficacy on a larger scale of PFPS patients. It is a multi-center clinical trial conducted at a total of 10 institutions, including Bundang Seoul National University Hospital, Seoul Asan Medical Center, and Myongji Hospital, with the goal of completing the trial within this year. Afterwards, the aim is to obtain regulatory approval from the Ministry of Food and Drug Safety next year and proceed with actual prescriptions.

Patellofemoral pain syndrome is a chronic condition characterized by pain around the patella covering the knee. Although the cause is unclear, it is known to occur when the knee is overused, and it is mainly characterized by pain when standing up after sitting for a long time. Rehabilitation exercise therapy is highly recommended as the most important treatment, but it is evaluated that many patients face difficulties in undergoing treatment due to economic and physical limitations. Even when treated, cognitive behavioral elements that assist long-term treatment of chronic pain and psychological therapy are known to play an important role in treatment outcomes.

Mora Cure is explained to address these unmet needs by providing stepwise exercise therapy and cognitive behavioral therapy together to help patients continue treatment consistently.

Yoon Chan, CEO of EverX, said, "We have taken a step forward in providing better medical environments for patients," adding, "In musculoskeletal diseases where pain relief and quality of life improvement are important, DTx is establishing itself as a new treatment option and a digital therapeutic solution that enhances medical accessibility, and we will strive to enable more patients to receive high-quality medical services."

This content was produced with the assistance of AI translation services.