Mediver Secures MFDS IND Approval for Digital Therapeutics Targeting Diabetic Peripheral Neuropathy

Mediver, a digital therapeutics platform company specializing in pain relief, led by CEO Seungkoo Yoo, is launching a clinical trial of its digital therapeutic device targeting patients with diabetic peripheral neuropathy. Mediver has received approval from the Ministry of Food and Drug Safety for its investigational device exemption (IDE) to evaluate the safety and efficacy of its digital therapeutic device.

This clinical trial is designed as a prospective, multicenter, exploratory study, employing a sham device comparison, double-blind, and randomized methodology. Korea University Guro Hospital and Dongguk University Ilsan Hospital are participating in the trial. The clinical trial is being conducted in collaboration with HealthTrial, a contract research organization (CRO) specializing in clinical trials. HealthTrial supports the entire clinical process, from trial design and operations to data management, and has extensive experience in the medical device and biohealth sectors.

Through its partnership with HealthTrial, Mediver aims to enhance the objectivity of the clinical trial and secure robust clinical data that meet regulatory standards. Mediver plans to compare its proprietary digital therapeutics device with a sham device to assess pain reduction effects and safety, and to focus on establishing clinical evidence for future pivotal studies.

The core of Mediver's digital therapeutics technology lies in its advancement beyond conventional physical therapy-based stimulation, by analyzing patients' neural signals and applying optimized microcurrents based on these signals—a "biological signal-based personalized pain control technology." Frequency-specific microcurrent technology applies targeted frequencies according to tissue and nerve conditions to manage pain, and is considered a non-invasive therapy that can relieve pain without medication.

This clinical trial is designed to verify the therapeutic potential of digital therapeutics based on medical devices for a specific indication (diabetic peripheral neuropathy). Previously, in 2023, Mediver entered into an agreement with the Ministry of Health and Welfare for the "Development of a biological signal-based personalized digital therapeutics solution device for rare and intractable pain" project and has been conducting related research. The company was also selected for the "Deep Tech TIPS" program by the Ministry of SMEs and Startups, and is working to advance its pain measurement and treatment technologies.

Following this exploratory clinical trial, Mediver plans to confirm the clinical efficacy of its digital therapeutics device in the field of diabetic peripheral neuropathy and seek regulatory approval from the Ministry of Food and Drug Safety. CEO Seungkoo Yoo stated, "This IDE approval marks a significant milestone in expanding Mediver’s non-invasive digital pain therapeutics technology into specific disease domains," and added, "We will successfully conduct the trial to present a precision digital therapeutics solution that can overcome the limitations of traditional medication-focused treatments."

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