Born from Clinical Needs in Orthopedic Care
Norien Biomedical is a spin-off from Taipei Medical University, founded to address challenges observed by orthopedic surgeons in clinical practice. Built on years of research and validation, our OsteoFill™ Gel platform is advancing toward commercialization as an injectable bone void filler. We are also exploring its potential to carry therapeutic agents for localized delivery, extending the platform from bone defect repair to broader applications in orthopedic care.
From Discovery to Clinical Impact
At Norien Biotech, we believe that the most meaningful advances in medicine come from bridging rigorous science with real-world clinical need. Our mission is to develop safe, effective, and commercially viable biomaterial solutions that improve patient outcomes globally.
Our flagship platform, OsteoFill™ Gel, exemplifies this philosophy — a thermoresponsive, osteoconductive hydrogel designed to address bone void filling and infection management in a single, bioresorbable formulation. We are committed to pursuing FDA 510(k) clearance and building the clinical evidence base that surgeons and regulators require.
Areas of Clinical Innovation
Our pipeline is built on a single thermoresponsive hydrogel platform, starting with orthopedic bone defect and infection applications, with future generations planned for pain management and oncology.
Principles That Guide Our Science
These values shape every decision we make — from laboratory protocols to partnership agreements.
Scientific Rigor
Every product decision is grounded in peer-reviewed evidence and validated through systematic pre-clinical research.
Patient-Centered Innovation
We design solutions around unmet clinical needs — improving outcomes for patients who have exhausted conventional treatment options.
Regulatory Integrity
We pursue rigorous testing and transparent communication with clinicians and regulators, including completed ISO 10993 biocompatibility testing and FDA Pre-Submission engagement.
Translational Focus
Our R&D pipeline is built to move discoveries from the laboratory to the clinic efficiently, without compromising safety or efficacy.
Global Ambition
Rooted in Taiwan, we pursue partnerships and regulatory pathways that position our technologies for international markets.
Collaborative Spirit
We partner with hospitals, universities, and industry leaders to accelerate development and broaden clinical impact.
Building a Pipeline from the Ground Up
From founding through biocompatibility testing and regulatory engagement, Norien Biotech has built the scientific and regulatory foundation for commercialization.
OsteoFill™ Platform Developed
Over three years, orthopedic surgeons and professors at Taipei Medical University developed the core thermoresponsive hydrogel technology — a platform that gels at body temperature to fill bone defects and deliver therapeutic agents locally.
Pre-Clinical Testing Completed
OsteoFill™ Gel successfully completed GLP biocompatibility testing, confirming its safety profile. Efficacy was further validated in an animal bone defect repair model, demonstrating the platform's ability to support bone regeneration in vivo.
FDA Pre-Submission Completed
FDA Pre-Submission (Q250896) completed, informing the regulatory pathway toward FDA 510(k) clearance.
Company Established in June 2026
Following a successful technology transfer from Taipei Medical University, Norien Biomedical was founded to commercialize the OsteoFill™ platform — completing the product commercialization framework and building toward expanded indications.
Seeking Strategic Partners
Actively pursuing clinical, investment, and distribution partnerships to accelerate commercialization.
Rooted in Taiwan, Built for the World
Norien Biotech (諾研生醫股份有限公司) is incorporated in Taiwan, a country with a strong tradition of biomedical innovation and a robust regulatory environment. We leverage Taiwan's world-class manufacturing capabilities and research infrastructure while pursuing international regulatory clearances — including FDA 510(k) — to bring our technologies to patients globally.
Interested in partnering with Norien Biotech?
We welcome clinical, academic, investment, and distribution partnerships.