SUSMED,Inc.
4263・Growth Market・Information & Communication
Business
SUSMED Inc. is a research and development-oriented company whose mission is "providing sustainable healthcare services through the use of ICT," pursuing two core business lines: developing therapeutic program medical devices (DTx) using smartphone apps, and providing clinical trial support systems utilizing blockchain and AI technology. Founded in 2015, the company listed on the TSE Growth market in December 2021. Its main customers are pharmaceutical companies (Shionogi & Co., Kyorin Pharmaceutical, Asuka Pharmaceutical, etc.) and academic research institutions (National Cancer Center, Tohoku University, The Jikei University School of Medicine, etc.). The company holds a pipeline across six areas—insomnia disorder, premenstrual syndrome, tinnitus, ACP, renal rehabilitation, and dizziness—and its App for Insomnia Disorder has already obtained manufacturing and marketing approval as of February 2023.
Business Model
In the DTx Product Business, the company earns revenue in three stages—upfront contract payments, development-progress-linked milestones, and post-launch royalties—based on joint R&D and sales agreements with pharmaceutical companies. Under the agreement with Shionogi & Co., Ltd. for the App for Insomnia Disorder, milestones of up to ¥4,100 million are planned. In the DTx Platform Business, the company provides a blockchain-based general-purpose clinical trial system (SUSMED SourceDataSync®) and a Machine Learning Automated Analysis System (Awesome Intelligence) to pharmaceutical companies and research institutions, building up stable recurring revenue.
Company Strengths
Obtained medical device manufacturing and marketing approval from the Ministry of Health, Labour and Welfare in February 2023. Following the deferral of insurance reimbursement listing under the FY2024 revision, the company filed a partial change approval application in August 2024 and obtained approval in September 2025. On September 4 of the same year, the company submitted an insurance coverage application, and procedures toward insurance reimbursement listing are currently underway. Under the sales partnership agreement with Shionogi & Co., Ltd., the company expects to receive milestone payments of up to ¥4,100 million.
In June 2022, the company entered into an outsourcing agreement with Aculys Pharma, Inc. for what became the world's first corporate clinical trial utilizing blockchain technology. Under the Gray Zone Resolution Scheme, the company obtained confirmation from the Ministry of Health, Labour and Welfare regarding the legality of omitting on-site SDV (source data verification). The technology was also adopted under the Cabinet Office's Regulatory Sandbox program, providing official confirmation of regulatory compliance.
The company has concluded three joint research and development / sales agreements: with Shionogi & Co., Ltd. (insomnia disorder, up to ¥4,100 million), Kyorin Pharmaceutical Co., Ltd. (tinnitus, up to ¥500 million), and Aska Pharmaceutical Co., Ltd. (premenstrual syndrome, up to ¥2,400 million). In FY2025 (ended June 2025), the company recognized revenue of ¥300 million in total from Aska Pharmaceutical, consisting of a ¥200 million upfront contract payment and a ¥100 million milestone payment, giving concrete shape to the future revenue pipeline.
ENVALITH's Perspective
Performance Trend
Business revenue for the nine months of Q3 FY2026 (ending June 2026) was ¥230 million (down 44.9% from ¥418 million in the same period of the previous year), and operating loss widened substantially to ¥345 million (compared with a loss of ¥147 million in the same period of the previous year). The main cause was the reversal of the ¥300 million milestone income (related to Shionogi & Co.) recorded in the DTx Product Business in the same period of the previous year. Selling, general and administrative expenses increased to ¥392 million (from ¥353 million in the same period of the previous year), indicating growing cost pressure. Combined with the annual results of the past five fiscal years (FY2022: revenue of ¥317 million, operating loss of ¥229 million; FY2023: ¥531 million, loss of ¥48 million; FY2024: ¥343 million, loss of ¥365 million; FY2025: ¥463 million, loss of ¥299 million), the structure in which performance swings widely depending on whether milestone income is recorded continues. Cash and deposits stood at ¥3,958 million, securing near-term development funding, but attention should be paid to the accelerating pace of cash consumption.
Growth Strategy
Maximizing long-term revenue through prioritizing insurance coverage and market launch of the App for Insomnia Disorder, alongside multiple pipeline advancements and platform expansion
Obtained partial approval for change in manufacturing and marketing approval matters in September 2025, and submitted a request for insurance coverage application in the same month. Plans to launch the product based on the sales partnership agreement with Shionogi & Co., Ltd. once the insurance point value is finalized. Following the launch, royalty income is expected to arise, leading to a significant change in the revenue structure.
Positive results were confirmed in a specific clinical research study, and a milestone payment of ¥100 million has already been received. Going forward, milestone income of up to ¥2.3 billion in total is expected depending on the development stage. Transition to a confirmatory trial represents the next revenue recognition opportunity.
The specific clinical research study in the joint development with Kyorin Pharmaceutical Co., Ltd. has been completed, and a memorandum of understanding regarding the addition of the company's role was concluded. Milestone income and royalty terms were increased, and a confirmatory trial has commenced. Progress continues toward the next milestone recognition.
Subject enrollment has begun in a company-sponsored clinical trial corresponding to a Phase II clinical trial. An industry-academia collaborative course was established with The Jikei University School of Medicine, aiming for social implementation. Being developed as a new revenue pipeline.
Promoting the accumulation of stable revenue through the acquisition of new adoption cases for SUSMED SourceDataSync® and continued use by existing customers. The start of corporate provision of an integrated venous disease registry system with Tohoku University has created a new use case for post-marketing surveillance of medical devices.
At the board of directors meeting on April 20, 2026, resolutions were passed regarding interior fitting-out construction and other work associated with the head office relocation. The planned investment amount is ¥92,400 thousand, with construction scheduled to begin in June 2026. The aim is to accommodate the increase in personnel and secure a highly scalable workspace, establishing a framework to support continuous business expansion.
Last updated: July 17, 2026