Rapid Approval Expected with Priority Review by Ministry of Food and Drug Safety
Digital healthcare startup Bell Therapeutics announced on June 23 that its digital therapeutic for insomnia, 'Sleep Thera,' has been designated as an innovative medical device (advanced technology category) by the Ministry of Food and Drug Safety.
With this designation, Bell Therapeutics is now eligible for priority review, laying the groundwork for rapid market entry in the future. Innovative medical devices can be sold in clinical settings for three to five years after market entry, either as non-reimbursed items or under selective reimbursement.
Sleep Thera is a new-concept medical device that treats insomnia by generating personalized digital stimulation based on biometric signals. The company expects that it will improve sleep quality faster and more effectively than existing insomnia treatment devices.
The technology and clinical results of Sleep Thera were presented this month at the 'SLEEP' academic conference in the United States. HCP Live, a U.S.-based bio healthcare media outlet, selected it as one of the '7 Noteworthy Studies at SLEEP,' drawing attention from international researchers.
Bell Therapeutics is a digital new drug platform startup that combines advanced neuroscience and sound technology. The company aims to solve problems in clinical settings through innovative solutions based on its world-class research and development capabilities and technological expertise.
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