Industrial Technology Research Institute

Technology Overview

ITRI has developed Dual-Phase Hydrogel, a groundbreaking biomedical material with high biocompatibility to address patient needs and enhance medical care. The hydrogel transitions from liquid at room temperature to gel at body temperature. This temperature-sensitive feature makes it perfect to be administered to injury sites for protection and recovery without open surgery. It can also be a carrier for drugs or cells, providing long-lasting therapeutic effects. Dual-Phase Hydrogel, with an FDA Master File for Devices (MAF) and QMS manufacture, offers various medical applications, including anti-adhesion membrane for many surgeries like spine surgery to prevent side-effect pain, or even surgery again, joint degeneration treatment already finished human clinical trial, and bone fracture/crack repair.

Features & Specifications

• Long-lasting effect
• Minimal invasiveness
• Treatment versatility

Applications & Benefits

• Preventing tissues from adhering to each other after patients undergo surgeries
• Improving safety for human applications
• Potential future application includes cardiovascular treatment that improves heart surgery outcomes

One-Stop Biomedical Services

• Listing Regulations Consulting: FDA/TFDA/CE application, medical device verification/export, medical device/medicine registration, IRB document organization, clinical trial application, and more.
• Technology Transfer: Bio-IT, diagnostics and precision medicine technology, regeneration medicine technology, natural medicine and healthcare technology, targeted drug and delivery technology.
• Model Translation: Domestic supply chain linkage, medical device design control, market analysis, strategy analysis of regulation in commercialization, and more.
• Preclinical/Clinical Trial: Functional safety assessments, clinical research organization linkage, clinical evaluation and analysis, clinical trial planning, clinical trial analysis and reports.
• Other Services: Quality system consulting, commercialization consulting, smart health solutions, software validation, medical device risk management, information security risk evaluation, technical documents preparation, business ecosystem linkage, and more.