Domestic No. 5 digital therapeutic (DTx) has emerged. Developed by NewLive, it is a tinnitus treatment DTx called 'SoriCLEAR'. NewLive is a DTx and electronic medicine development startup founded in August 2018 by Professor Sang Jae-jun of the Department of Otorhinolaryngology at Korea University Guro Hospital.
Digital therapeutics prevent, manage, and treat diseases using software instead of pills or injections. Like new drugs, they must prove their therapeutic effects through exploratory and confirmatory clinical trials before receiving approval from the Ministry of Food and Drug Safety. Patients can use digital therapeutics with a physician’s prescription.
According to NewLive on the 21st, SoriCLEAR obtained item approval from the Ministry of Food and Drug Safety on the 17th. SoriCLEAR is a program that predicts tinnitus (耳鳴) using artificial intelligence (AI) and provides personalized treatment.
Tinnitus is a condition where auditory cells are damaged, causing mechanical noise or wind sounds to resonate in the ears or head even without external sound stimulation. It can lead to concentration disorders, anxiety, and depression. NewLive has developed DTx 'SoriCLEAR' to treat tinnitus cognitive behavior and electronic medicine 'Soricle' to treat tinnitus.
SoriCLEAR quantifies factors such as the patient’s age, gender, tinnitus frequency, and size, using AI to predict the patient’s disability factors and treatment targets, then provides the most appropriate tinnitus treatment program tailored to the patient. It is a hospital-use DTx, allowing medical personnel to download the app to use for patients.
SoriCLEAR is the fifth domestically produced DTx following Aimmed’s insomnia cognitive enhancement therapeutic 'Somz', Welt’s insomnia cognitive enhancement therapeutic 'WELT-I', Newnap’s stroke patient visual impairment improvement therapeutic 'VIVID Brain', and Share & Service’s respiratory rehabilitation exercise therapeutic 'EasyBreath'.
CEO Song is considering applying for an evaluation of new medical technology for SoriCLEAR. The Health Insurance Review and Assessment Service verifies whether a technology is already registered in the national health insurance, a process that takes 30 to 60 days. If confirmed as a new technology, it must undergo safety and efficacy evaluations lasting up to 250 days. Only after passing the evaluation will it take about 100 days for it to be registered in health insurance. Following this process, it can be used as either covered or non-covered by health insurance in medical settings. It is expected to take an additional year for patients to be able to use SoriCLEAR.
Earlier, in November of last year, the Ministry of Health and Welfare and the Ministry of Food and Drug Safety improved the system to allow for immediate market entry by simultaneously conducting approval with the Ministry of Food and Drug Safety and the verification of new technologies with the review agency. However, this system is not yet implemented as it requires legislative amendments.
With the domestic item approval for SoriCLEAR, NewLive also received item approval for the electronic medicine Soricle in Brazil. This now allows the company to target the South American market, primarily Brazil.
Electronic medicine is a device that treats diseases by stimulating the brain. Soricle is a headphone device used on both ears, treating by electrically stimulating the ear area (external iliac) connected to the vagus nerve, which regulates the autonomic nervous system. The electrically controlled stimulation by AI increases brain blood flow and neurotransmitters, calming the excitation of the auditory cortex that causes tinnitus. Soricle won an innovation award in the digital healthcare field at the world's largest information technology (IT) exhibition in 2023.
CEO Song noted, "Tinnitus is one of the representative intractable diseases dealt with in otorhinolaryngology," and added, "I hope many tinnitus patients both domestically and internationally achieve therapeutic effects through DTx SoriCLEAR and electronic medicine Soricle."