WELT-I, a digital insomnia therapeutic device that Handok and digital healthcare company WELT collaborated on, has been approved by the Ministry of Food and Drug Safety on April 19.

WELT-I is based on medically proven cognitive behavioral therapy. Cognitive behavioral therapy is recommended as first-line treatment in clinical guidelines.

In clinical trials involving 120 patients with insomnia, it was shown that WELT-I significantly improved sleep efficiency. Sleep efficiency is an objective quantitative metric based on patients’ sleep data.

The use of WELT-I requires a doctor’s prescription.

When an insomnia patient who has been prescribed the device installs WELT-I on his/her smartphone, it delivers ▲ sleep restriction therapy ▲ sleep hygiene education ▲ stimulus control therapy ▲ cognitive restructuring, and ▲ relaxation therapy for 8 weeks to improve insomnia symptoms according to the patient’s sleep patterns.

Handok and WELT plan to make meaningful performances in the emerging area of digital therapeutic devices by combining their business capabilities, including licensing, insurance coverage, marketing, and sales.

Mr. Kim Young-Jin, Chairman of Handok, said, "In order to commercialize successfully digital therapeutic devices after the hurdle of approval, not only R&D but also collaboration with academia and medical staff, and our own experience and capabilities in commercialization are very important.

We expect the digital therapeutic device WELT-I to be a new treatment option for insomnia patients who have suffered due to low accessibility and limitations of cognitive behavioral therapy in the domestic treatment environment.“

Dr. Kang Sungjee, CEO of WELT, said, "We are pleased that our first pipeline, WELT-I, has been approved on the basis of solid scientific evidence. We will continue successful commercialization as well as development of the device in synergy with Handok, which leads the domestic sleeping pill market.“

Meanwhile, WELT-I has been designated as the first product out of the integrated review system for innovative medical devices in Korea by the Ministry of Health and Welfare.

The integrated review of innovative medical devices is a system that the government shortened the total review period from 390 days to 80 days in September 2022 in order to expedite the introduction of the innovative products into the medical field.

WELT is a digital healthcare startup spun out of Samsung Electronics in 2016.

It became the first Asian company to be elected to the board of the global Digital Therapeutics Association (DTA) in November 2022. To date, the company has raised 14 billion won in cumulative investment from Samsung, Handok, IMM, and Smilegate.

[WIKI KOREA=Cho Pil Hyun, Staff Reporter]

chop23@wikileaks-kr.org

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