WELT’s insomnia digital treatment device, WELT-I, became Korea’s second approved  digital therapeutics (DTx) on Wednesday.

WELT-I is an insomnia treatment aimed at correcting psychological, behavioral, and cognitive factors that sustain or worsen insomnia. The device was developed to deliver treatment based on cognitive behavioral therapy (CBT) which is recommended as a first-line treatment in clinical guidelines for insomnia.

The device, which requires a doctor's prescription, was approved based on a clinical trial conducted on 120 patients with insomnia where WELT-I demonstrated significant improvements in sleep efficiency. Sleep efficiency was objectively calculated as the percentage of total sleep time/time in bed based on the participants’ sleep data.

Based on the patient's sleep diary data, this device is classified as a software as a medical device (SaMD) that improves insomnia by performing personalized sleep time, the intervention of patient behavior to improve sleep quality, analysis of sleep disturbance habits, and relaxation therapy delivered for eight weeks to reduce tension and anxiety.

Following the approval by the MFDS, Handok, and WELT will strengthen their strategic cooperation for the commercialization of WELT-I. Both companies entered into an equity investment and partnership in 2021, with Handok retaining the domestic rights to WELT-I including licensing, reimbursement, marketing, and sales.

Handok is responsible for the distribution of the most prescribed sleeping pill, Stilnox produced by Sanofi, and has secured business competitiveness in central nervous system (CNS) diseases and rare diseases through various products.

"We believe that 'WELT-I' can be a new treatment option for insomnia patients who have suffered from limited CBT options for insomnia domestically," said Handok Chairman Kim Young-jin. We will do our best to ensure that 'WELT-I' provides practical benefits to patients and with a successful commercialization model."

WELT-I was also designated as an innovative medical device in September last year thus reducing the total review period from 380 days to 80 days.

"We are very pleased that our first pipeline, has received approval based on solid scientific evidence and will continue to work in synergy with Handok to successfully develop and commercialize WELT-I," said WELT’s CEO, Sean Kang. “The rapid establishment of regulations and customized counseling by the MFDS were the driving forces behind the rapid launch of Dtx in Korea and we expect this to help us enter the medical field faster and get health insurance coverage.”