JETRO Selects Five Japanese Healthcare Startups for U.S. Clinical Evidence Development Program
Aug 10, 2026
J-StarX Medical Data Utilization Program to support evidence strategies for U.S. market entry
JETRO has selected five Japanese healthcare startups to participate in the J-StarX Medical Data Utilization Program, a U.S.-focused program designed to help Japanese medtech, healthtech, and digital health startups prepare for market entry by developing clinical evidence strategies relevant to the U.S. healthcare system.
The program will run from late July 2026 through early March 2027 and will be delivered in partnership with TheraNova LLC, a San Francisco-based biomedical device incubator specializing in medical devices and digital health. The program is implemented with the support of Japan’s Ministry of Economy, Trade and Industry (METI).
Dr. Daniel Burnett, CEO of TheraNova LLC, said: "We're excited to partner with JETRO on this program, and genuinely impressed by the caliber of startups that applied. Each company selected is well-positioned to gather meaningful clinical data in the US — a major milestone in their development."
For medical devices and digital health products entering the U.S. market, FDA clearance or approval is only one part of the commercialization process. Companies may also need evidence demonstrating safety, effectiveness, clinical utility, usability, and economic value in order to support reimbursement, adoption by healthcare providers, and engagement with investors or strategic partners.
Through this program, JETRO and TheraNova will support participating startups in identifying the clinical evidence needed for their products and in developing individualized strategies for clinical study design, data generation, validation, U.S. regulatory planning, reimbursement considerations, and commercialization. Rather than applying a one-size-fits-all approach, the program will work backward from each company’s product, target users, intended use, and U.S. market strategy.
Program Activities
The program will be conducted in two phases.
Phase 1: Study Preparation and U.S. Immersion
Late July – early October 2026
Participants will work on clinical study planning, identification of required data, selection of appropriate data sources, and engagement with potential U.S. research partners, healthcare institutions, and key opinion leaders. Support may also include preparation for FDA interactions, including Q-Submission meetings, where applicable, as well as preparation for contracting with research partners and Institutional Review Board applications, where required.
This phase will also include educational sessions on quality management, regulatory affairs, medical ethics, HIPAA, data integrity, and reimbursement, as well as visits to U.S. healthcare institutions and clinical research partners primarily in the San Francisco area.
Phase 2: Data Generation, Validation, and Graduation Showcase
Mid-October 2026 – March 2027
Based on each company’s research plan, participants will proceed with clinical data generation, validation, and related activities. Depending on each company’s needs, this may include the use of existing datasets, retrospective studies, prospective studies, and other forms of clinical data collection.
Individual mentoring by U.S. experts will support data analysis and interpretation, integration of findings into regulatory and reimbursement strategies, engagement with key opinion leaders, fundraising preparation, and presentation of study results.
During the final week of the program, JETRO plans to hold a graduation showcase in the United States, where participating startups will present their results and future business plans to healthcare professionals, investors, accelerators, and other ecosystem stakeholders.
Selected Startups
ayumo Inc. develops medical technologies using proprietary gait-recognition technology and deep-learning models combined with medical insights. Its solutions analyze walking videos to support the assessment of underlying conditions and postoperative outcomes.
Cranebio Co., Ltd. develops affordable, highly sensitive next-generation self-testing solutions, particularly in women’s health. Its nucleic-acid-based self-testing platform has potential applications including self-administered HPV testing, infectious disease detection, and bacterial detection.
DELISPECT develops a proprietary predictive model for delirium, with the aim of addressing clinical challenges associated with delirium, including poorer patient outcomes, increased burden on healthcare professionals, and impacts on hospital operations.
LIFESCAPES Inc. develops medical devices and digital solutions based on Brain-Computer Interface (BCI) technology using electroencephalography (EEG). The company aims to support functional recovery for patients affected by conditions such as stroke and spinal cord injury.
Splink, Inc. is a medical AI startup focused on brain health and central nervous system disorders. Its products include the “CQ test,” a cognitive function assessment tool, and AI-based brain imaging software.
About TheraNova LLC
TheraNova LLC is a San Francisco-based biomedical device incubator specializing in medical devices and digital health. The organization supports companies across areas including product design, prototyping, clinical studies, FDA regulatory strategy, reimbursement, intellectual property, fundraising, and commercialization.
About JETRO
The Japan External Trade Organization (JETRO) is a government-related organization that promotes trade and investment between Japan and the rest of the world.
JETRO supports the global expansion of Japanese companies, including startups, as well as foreign companies entering the Japanese market. In the startup sector, JETRO works with accelerators, investors, corporations, and other ecosystem partners around the world to support the international growth of innovative Japanese companies.
Contact
JETRO Innovation Department
Startup Division
IVD@jetro.go.jp
