サスメド operates DTx product and DTx platform businesses and is scheduled to begin the launch of an app for treating sleep disorders in June 2026. It uses blockchain in clinical trial data management and aims to expand its development pipeline through joint research with academic institutions.
サスメド has defined its business segments as the DTx product business and the DTx platform business, developing therapeutic apps and providing clinical trial support systems. In the DTx product business, it plans to begin the launch of Medcle, an app intended to support the treatment of insomnia disorders, in June 2026. In the DTx platform business, it supports efficiency improvements in pharmaceutical companies’ research through a clinical trial system using blockchain technology. Revenue is recorded as service usage fees from contracted companies.
The company is strengthening its relationships with academic institutions and academic societies, accumulating expertise and expanding its development pipeline through joint research and development with academia. As of the end of the fiscal year ended June 2026, the cumulative number of projects selected by AMED and NEDO was 21, the cumulative number of joint research partners was 24 companies and institutions, the number of patents obtained was 32, and the DTx development pipeline comprised 11 projects.
In the DTx product business, the company develops therapeutic apps and plans to obtain approval as medical devices under the Pharmaceuticals and Medical Devices Act before bringing them to market. Based on clinical data, therapeutic apps provide treatment interventions optimized for each patient without the involvement of a physician, and medical institutions receive compensation based on the number of prescriptions. Revenue models include in-house development and sales, as well as joint development with pharmaceutical companies and post-launch sales agreements. Insomnia disorders are cited as an initial area of focus. Multiple therapeutic apps have been approved overseas, and approval processes have progressed relatively further in Europe and the United States, while Japan is developing an approval framework for therapeutic apps.
Regarding overseas approval trends and differences in development periods and costs between Japan and other countries, the development period for therapeutic apps is said to be approximately 5 to 6 years, shorter than for pharmaceuticals. The report also discusses the track record of insurance coverage in Japan and future adoption policies.