The primary indication for this technology is pancreatic cancer, where focused ultrasound enables enhanced delivery of chemotherapeutic agents to the dense and poorly perfused tumor microenvironment.
The platform has strong scalability potential and can be applied to a broad range of solid tumors, including pancreas, sarcoma, liver, breast, prostate cancers. Its non-invasive and targeted mechanism allows adaptation across multiple therapeutic areas, supporting future expansion into combination therapies and precision oncology applications.
Stage
Pivotal clinical trial phases (FDA IDE Approval in 2025)
IMD10 Pivotal Trial
Indication
- BRPC or LAPC
Region
- United States, Republic of Korea
Intervention
- In both the experimental and control groups, the chemotherapy regimen will be administered based on the institu tional standard of care (SOC)- In the experimental group, the IMD10 system will be applied in combination with the chemotherapy regimen during all treatment cycles.
Endpoints
- Primary endpoint: Overall Survival (OS)- Secondary endpoint: Quality of Life, Objective response rate (ORR), Progression-free survival (PFS), etc.
