Bioresorbable thermal sensitive hydrogel is a new material in regenerative medicine. At low temperatures, it is in liquid form. However, at body temperature it becomes a gel, which means that it can support revised clinical methods for implantable biomedical material, lower the risks associated with exploratory surgery, and decrease the number of surgeries required. For example, in the application of bone repair medical material the gel can be used to deliver antibiotics, drugs, or growth factors to achieve regeneration repair without the need for surgery. ITRI’s bioresorbable thermal sensitive hydrogel solves the acidification problem which occurs during the decomposition process. This effectively expands the gel’s temperature range and improves safety for human applications. During the first stage, knee joint maintenance products were used as the application target for human trials. Potential future applications may include other soft and hard tissue repair, cosmetic medicine, and dentistry.
A patented bioresorbable thermal sensitive hydrogel means that surgery is no longer the only solution, and that injections can replace surgery to improve curative effects and reduce the number of treatments required. After the establishment of ITRI’s GMP trial production procedure, previous verification reviewed by the NTUH Research Ethics Committee on clinical safety and effectiveness, and clinical trials approved by the Ministry of Health and Welfare, human trials were initiated. This new material will increase the value added and competitiveness of Taiwan’s synthetic medical polymer industry and end its long-term reliance on imported raw materials.
Applications & Benefits
- Solving the acidification problem which occurs during the decomposition process.
- Expanding the gel’s temperature range and improves safety for human applications.
- Potential future applications may include other soft and hard tissue repair, cosmetic medicine, and dentistry.
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.