In the early 2010s, the term 'digital therapeutics' was unfamiliar in the domestic medical community. The concept of treating patients with software, rather than drugs or surgery, was strange and unimaginable in a medical setting. A neurologist who encountered numerous patients suffering from neurological disorders chose this new path. This was to create a digital therapeutic that induces recovery by training damaged brains, known as 'the medicine the brain consumes.'
Professor Kang Dong-hwa of Asan Medical Center founded NewNeps in 2017 and developed the digital therapeutic 'VividBrain' to treat visual impairments due to stroke, commercializing it for the first time in the world. This therapeutic received clinical trial approval for digital therapeutics in South Korea in 2019 and was designated as an innovative medical technology in 2023. Last year, it became the third domestic digital therapeutic to receive final approval from the Ministry of Food and Drug Safety.
◇Treating visual impairments from the brain, not the eyes
On the 18th of last month, Kang Dong-hwa, the CEO met at the NewNeps headquarters in Asan Medical Center, stating, 'About 20% of stroke patients experience visual impairments, but it has not received much attention compared to paralysis or speech disorders,' and explained, 'Visual impairments are caused by problems in the brain, not the eyes. If even one of the pathways where visual information is processed in the occipital lobe is damaged, it can have serious impacts on daily life.' The issue is that there are hardly any effective treatments for visual impairments. Most patients had no choice but to hope for natural recovery or adapt.
VividBrain is a therapeutic that stimulates the optic nerve circuit and induces the brain's 'plasticity' through repetitive visual training. Plasticity is a biological phenomenon where the brain creates new circuits to compensate for damaged areas and recover. NewNeps systematically designed this process. After analyzing the patient's damaged visual areas using artificial intelligence (AI) algorithms, it provides immersive and personalized training within a virtual reality (VR) environment. The training results are collected and analyzed in real-time, providing immediate feedback to the patients.
One of the training exercises seen during VividBrain training involved displaying two different patterns for a short time, measured in hundreds of milliseconds (1/1000th of a second), and having the patient determine if they matched. As the accuracy rate increased, the patterns became more vague, thus increasing the difficulty. Another task involved distinguishing the rotation direction of a rotating striped pattern. While it may seem like a simple game, the task is precisely designed to stimulate the visual brain circuits.
Kang noted, 'Repetitively performing visual tasks, pattern recognition, and direction differentiation in a VR environment leads to unconscious learning in the brain' and likened it to how 'the mother of Han Seok-bong made her son practice calligraphy in the dark to improve his skills.' He emphasized that through repetitive training, the brain's visual functions are restored.
◇Targeting market entry: Japan, the Middle East, and Southeast Asia
VividBrain is used through a prescription from a doctor, with a standard training regimen of 30 minutes a day, five times a week, for 12 weeks. NewNeps proved its therapeutic effect through a large-scale confirmatory clinical trial involving 12 university hospitals last year. In a clinical trial involving a total of 104 patients, it met the criteria for both primary and secondary efficacy evaluations. Some patients also formed new brain circuits and showed substantial improvements, reaching a near-complete recovery.
The therapeutic effect of VividBrain can also be explained by the NNT (Number Needed to Treat). This represents the average number of patients that need to be treated to achieve the desired effect in one patient. While the NNT for aspirin prescriptions to prevent stroke recurrence is 140, VividBrain has an NNT of only 4. Kang stated, 'It’s very rare for a digital therapeutic to achieve such a figure,' adding that 'it is a significant indicator that the technology we created is genuinely helping patients.'
The training method is intuitive and highly engaging, which also results in high 'adherence.' Adherence indicates how well patients follow their doctor's prescriptions. The average adherence rate among clinical trial participants was 85.6%, with some patients participating over 200%.
VividBrain has been officially prescribed at Asan Medical Center since September 2024. NewNeps also developed a dedicated prescription platform called 'Eum' tailored to digital therapeutics, making it easily accessible for hospitals, doctors, and patients. Currently, over 20 hospitals nationwide are collaborating with NewNeps, centered around Asan Medical Center, and plans are in place for expansion to regional stroke centers.
So far, NewNeps has raised a cumulative investment of 21.9 billion won and achieved 84 patent registrations, establishing itself as a technology-based medical innovation corporation. The company is also accelerating its entry into overseas markets. NewNeps has applied for CE certification in Germany and is expected to start generating revenue in the European market as early as next year.
Kang noted, 'Germany is a country where digital therapeutics have established themselves institutionally, with low localization barriers and a well-established infrastructure and insurance system, making it a suitable first overseas market.' He also mentioned that 'the U.S. market, with its high potential, should be approached carefully but is a market we must challenge.' The company is also sequentially exploring entry into markets in Japan, the Middle East, and Southeast Asia.
◇Establishing institutional frameworks and exploring treatment area expansion
While the digital therapeutic market is steadily growing, it has not yet established itself within the domestic medical regulatory framework. Hospitals have not clearly defined who will manage this technology or which department will operate it. Kang remarked, 'There are numerous barriers to the introduction of digital therapeutics into the medical field,' adding that 'the biggest challenge in the introduction of digital therapeutics is the process of finding solutions through collaboration with the field and streamlining processes.'
Kang expressed confidence in the potential of the digital therapeutic industry. He mentioned, 'Some doctors question why digital therapeutics should be used, but I see this as part of the process of acceptance.' He added, 'In the past, even credit cards seemed unfamiliar, but now everyone uses them as a matter of course. Likewise, digital-based diagnostic, preventive, management, and treatment technologies must be embraced in the medical community at some point.'
Recently, NewNeps was selected as one of the top 10 projects for the 2025 multi-ministerial full-cycle medical device research and development project group, receiving support for clinical trials and necessary assistance for global market entry. Kang explained, 'We receive feedback on clinical data from a specialized advisory group, and it also provides significant help in advising our market expansion strategy,' adding that, 'It connects us to business opportunities for overseas expansion.'
NewNeps is also exploring expansions in treatment areas. Kang stated, 'We plan to expand our pipeline into various fields such as stroke, visual impairments, strabismus, and macular degeneration, broadening the possibilities for the convergence of digital technology and medicine.' He further believed that 'although this path is challenging, it can lead to greater heights if we fly against the wind.'