Aribio announced on December 30 that its independently developed digital dementia therapeutic device, "GVD-01," has been selected as the final candidate for the "New Health Technology Assessment Guide Service" by the National Evidence-based Healthcare Collaborating Agency (NECA).
With this selection, Aribio will receive comprehensive support from the professional institution throughout the entire process, including the pivotal clinical trial of GVD-01 scheduled for next year, the new health technology assessment, commercialization, and market entry. Specifically, NECA will provide support such as: establishing the Target Technology Profile (TTP) for GVD-01, clinical expert consultations, evidence preview, evidence navigation, and the provision of a comprehensive diagnostic report.
Through this, Aribio has established a strategic foundation to obtain global medical device approvals and achieve early commercialization not only in Korea but also in major overseas markets.
GVD-01 is a non-invasive digital dementia therapeutic device developed based on the association between 40 Hertz (Hz) gamma waves and decreased cerebral blood flow with the pathophysiology of Alzheimer's disease. It features transcranial vibroacoustic stimulation (tVAS) technology, which helps activate neural networks and protect brain function. Designed as a headband, it can be used relatively easily by elderly dementia patients and is highly regarded for its potential as a non-pharmacological treatment option.
This year, Aribio successfully completed exploratory clinical trials of GVD-01 at university hospitals and has now entered the pivotal clinical trial phase, strengthening both clinical efficacy and institutional validity. The exploratory trial results showed significant improvements in multiple assessment indicators related to cognitive function, brain function, and brain structure in patients with early-stage Alzheimer's disease. The company has also begun designing the pivotal clinical trial, taking into account real-world clinical application and institutional evaluation.
In addition, Aribio is accelerating the completion of global Phase 3 clinical trials for its oral Alzheimer's disease treatment, "AR1001." By expanding its portfolio to include digital therapeutics, the company now possesses global competitiveness in dementia treatment, encompassing both pharmaceutical and non-pharmaceutical options.
An Aribio representative stated, "To facilitate the global expansion of GVD-01, we are actively pursuing research and business collaborations with partners in the United States, Europe, Japan, and the Middle East. After completing the pivotal clinical trial and the domestic new health technology assessment, we plan to sequentially obtain medical device approvals in major countries, including the United States Food and Drug Administration, by 2027."
Meanwhile, Aribio is in the process of merging with Kosdaq-listed company Solux, with the scheduled merger date set for March 27, 2026.
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