Bell Therapeutics, a neuroscience-based digital healthcare startup, announced on the 26th that its insomnia digital therapeutic, Sleep Thera, has obtained the European Union (EU) medical device certification, CE MDR.

CE MDR is a stringent medical device regulation that must be met for entry into the European market. With this certification, Bell Therapeutics has secured the qualification to market Sleep Thera in the EU and other regions requiring CE certification.

Bell Therapeutics is developing a digital drug platform that integrates neuroscience and sound technology. Its proprietary Sonified Neuromodulation platform technology is the foundation for a digital therapeutic pipeline targeting multiple indications, including insomnia and cochlear implant auditory rehabilitation.

To expand into global markets, Bell Therapeutics has established a U.S. subsidiary and has been working on a multilingual global version of its product. The company explained that the CE MDR certification is a result of these efforts to enhance Sleep Thera’s global version, marking international recognition of Korea’s independent technological capabilities.

The U.S. subsidiary serves as a key base for global market expansion, focusing on business development, go-to-market strategies, licensing out (L/O), and presentations at international conferences.

Leading Bell Therapeutics’ global strategy is Jun-Seon Ryu, Head of the U.S. subsidiary. Ryu, a graduate of UC San Diego’s economics program, has gained expertise in healthcare IT and global strategy through his experience at Accenture US and BCG Korea. Leveraging this expertise, Bell Therapeutics is accelerating its global expansion with a refined localization strategy.

Jae-Eun Lee, CEO of Bell Therapeutics, stated, “We have positioned our U.S. subsidiary as a forward base for global expansion, establishing strategies for local medical device approvals and reimbursement system entry. With the CE MDR certification, we aim to strengthen our presence not only in the U.S. but also in the European market, accelerating market expansion through the establishment of a German subsidiary and entry into the DiGA system.”

The DiGA system is a digital healthcare reimbursement program overseen by Germany’s Federal Institute for Drugs and Medical Devices (BfArM). It enables digital therapeutics to be covered by health insurance and prescribed by physicians. Bell Therapeutics emphasized that the program offers strong incentives for digital therapeutic companies by allowing for rapid market entry and insurance reimbursement. The company intends to use this pathway for swift entry into the German market.

Going forward, Bell Therapeutics plans to accelerate the development of digital therapeutics targeting various indications, starting with insomnia and expanding to cochlear implant auditory rehabilitation.