HippoTNC Begins Hospital Prescriptions for Depression Treatment DTx "BlueKare"

Commercialization Accelerated with Deferred New Medical Technology Evaluation

HippoTNC announced on April 13 that its depression treatment software, BlueKare, has been designated by the Ministry of Health and Welfare as subject to deferred new medical technology evaluation, allowing for the start of full-scale hospital prescriptions.

BlueKare is the only digital therapeutic (DTx) for depression treatment in Korea that has obtained both Class III item approval from the Ministry of Food and Drug Safety and innovative medical device certification. It is a mobile software medical device (mSaMD) based on cognitive behavioral therapy (CBT).

Currently, major tertiary hospitals are introducing BlueKare prescriptions, and the solution integrates cognitive and emotional training, record-based self-awareness, and AI-powered personalized feedback features to provide personalized treatment based on real-world data. According to the company, a confirmatory clinical trial conducted at three university hospitals previously showed that after eight weeks of use, the Beck Depression Inventory (BDI) score decreased by an average of 13.34 points. The data confirmed not only alleviation of depression symptoms but also improvements in overall mental health indicators such as anxiety and stress.

In particular, BlueKare is designed to incorporate gamification elements, allowing patients to enjoyably engage in the treatment process without relying solely on medication.

HippoTNC plans to secure references centered on tertiary general hospitals and gradually expand distribution to primary and secondary hospitals, thereby accelerating its expansion in the digital therapeutics market. The company also aims to enter overseas markets through the U.S. Food and Drug Administration (FDA) 510(k) clearance and global joint research.

Taemyung Jung, CEO of HippoTNC, stated, "It is significant that BlueKare has established a foundation for utilization in clinical settings. We will continue our efforts to bring hope to those suffering from depression."

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