AIMMED’s Somzz ushers in digital therapeutic device market in Korea

South Korea’s health and drug safety authority has cleared Somzz to treat patients with sleep disorders, a dynamic move that is expected to vitalize the local digital health field with a series of new digital therapeutic devices in the pipeline.

“We have decided to give approval to AIMMED’s digital insomnia treatment device Somzz,” Minister of Food and Drug Safety Oh Yu-kyoung said in a press briefing on Wednesday. “This indigenous technology has ushered in a new digital therapeutic era in Korea.”

Somzz’s approval as Korea’s first digital therapeutic device is expected to foster growth of the local digital therapeutic market amid growing interest in digital medical devices since the COVID-19 pandemic hit. Korea has given the green light to 17 clinical tests for homegrown digital therapeutics, including those developed by frontrunners WELT Corp., nunaps Co. HAII Corp. and Emocog Inc.

The global digital therapeutic market has also gained traction since the US Food and Drug Administration’s (FDA) clearance of Pear Therapeutics’ reSET for the treatment of patients with substance use disorder in 2017.

Digital therapeutics are considered the latest revolution in drug development following traditional chemical biology and biotech-based medicines. It also costs less time and money to develop digital medical devices than traditional chemistry and bio-based medicines.

SOMZZ BY AIMMED

Somzz is a mobile app developed to treat patients with sleep disorders, using cognitive behavioral treatment, according to AIMMED Co., the homegrown digital health management technology company founded in 1999.

Insomnia patients prescribed Somzz will have sleep habit training through various programs of the app -- such as sleep journals, caffeine intake monitoring and breathing training -- to improve sleep efficiency. They will have real-time feedback from doctors and behavioral intervention, according to AIMMED.

The drug safety ministry has confirmed Somzz’s therapeutic efficacy in improving sleep efficiency through clinical tests administered by local medical institutions to insomnia patients for six to nine weeks.

AIMMED Chief Executive Officer Lim Jin-hwan expects that local general hospitals will start prescribing Somzz to insomnia patients two to three months after it passes the institutional review board’s evaluation and its health insurance reimbursement rate is determined.

He expects small clinics will be able to prescribe Somzz later, while the company is developing its non-prescription version.

AIMMED is currently developing other digital therapeutics for Attention-Deficit/Hyperactivity Disorder (ADHD), mild cognitive impairment, anxiety and panic disorders as well as cancer management, of which the first two treatment devices are due to be launched later this year or next, said Lim.

Write to Ji-Hyun Lee at bluesky@hankyung.com

Sookyung Seo edited this article.