Dragonfly "Full-scale Clinical Trial of Game-type Digital Therapeutic 'Guardians DTx' Begins"

Dragonfly's game-type digital therapeutic 'Guardians DTx (tentative name)' announced on the 4th that it will proceed with clinical trials after obtaining IRB approval and approval for the medical device clinical trial plan.

Within the first half of this year, Guardians DTx will complete all preparations and officially start the 'exploratory clinical trial,' the first hurdle for digital therapeutic product approval. While conducting this clinical trial, the company plans to establish a more segmented development strategy to strengthen market competitiveness and reorganize existing content to secure technology. Dragonfly aims not only to focus on simple development but also to create a product with competitiveness and clear targeting that can guarantee efficacy and safety in treating actual patients.

Digital therapeutics refer to software medical devices and, unlike drug therapeutics that generally require long clinical approval times through phases 1, 2, and 3, can be commercialized after passing two approval stages: exploratory and confirmatory clinical trials. The clinical approval process is relatively less costly and time-consuming, enabling low-cost and high-efficiency outcomes, and the installed device or program can be reused. Additionally, if designated as a subject of the newly introduced 'integrated review' system last year, the general review period of 390 days can be significantly reduced to an evaluation within 80 days.

According to Won Hee-mok, advisor at the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, the global healthcare market is expected to grow at an average annual rate of 17%, from 2,603 trillion KRW in 2021 to 3,770 trillion KRW in 2027, and the domestic healthcare market is also expected to grow from 38.9 trillion KRW to 54.6 trillion KRW during the same period. In line with these market prospects, the government announced it will invest 559.4 billion KRW this year in bio-origin technology development, especially focusing on promising future fields such as neuroscience, microbiome, and genomics.

With the first approval of a digital therapeutic device completed this year, the digital therapeutics market is expected to grow rapidly with full government support. The company emphasized that there is great anticipation following news that support and fostering will be promoted focusing on the 'brain convergence technology' field that Dragonfly is developing.

A Dragonfly representative said, “Guardians DTx was already recognized as a medical device last year and received government research funding. This year, as clinical trials officially begin, we will accelerate commercialization,” adding, “This year, as the first game company to participate in Korea's largest medical device exhibition (KIMES), we received significant attention, which provided an opportunity to communicate with many medical industry stakeholders.”