February 17, 2025
Sirindhorn Conference Room, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok
The National Metal and Materials Technology Center (MTEC), NSTDA, and the Faculty of Medicine Siriraj Hospital, Mahidol University, signed an agreement for the clinical testing of OSSICURE Bone Graft, a bone substitute product. The study aims to compare its efficacy and safety with the reference product Infuse Bone Graft for lumbar spinal fusion.
The signing ceremony was co-chaired by Associate Professor Dr. Yoschanun Wongsawat, Vice President for Research at Mahidol University, and Dr. Sombun Sahasittiwat, Deputy Executive Director of NSTDA. Also present as witnesses were Professor Dr. Apichat Asavamongkolkul, Dean of the Faculty of Medicine Siriraj Hospital, Mahidol University, and Associate Professor Dr. Toemsak Srikhirin, Director of MTEC.
This agreement marks a significant step in advancing medical innovation, ensuring safer and more effective treatments for the public.
Associate Professor Dr. Yoschanun Wongsawat, Vice President for Research at Mahidol University, stated that the development of OSSICURE Bone Graft aligns with Mahidol University’s mission to drive innovation in healthcare solutions for the nation. This clinical trial is the result of a collaboration between NSTDA’s technological expertise and Siriraj’s medical capabilities, which include both highly qualified personnel and a sufficient number of patients for testing. This partnership is expected to drive the research toward successful outcomes, ultimately benefiting the country’s public healthcare system in the long term.
Professor Dr. Apichat Asavamongkolkul, Dean of the Faculty of Medicine Siriraj Hospital, Mahidol University, stated that spinal disorders, particularly degenerative disc disease, are among the major health challenges affecting the Thai population, especially working-age adults and the elderly. These conditions often lead to chronic neck and back pain. Statistics indicate that over 403 million people worldwide and approximately 104 million people in Southeast Asia are affected by these conditions.
While most cases do not require surgery, some patients need spinal fusion surgery, which currently relies on autografts (bone from the patient’s own body) or allografts (donor bone). However, these methods come with limitations, including high costs, risks of complications, and prolonged recovery times.
The development of OSSICURE Bone Graft offers a new alternative, enhancing treatment accessibility with high efficacy as a bone substitute. Laboratory and animal studies have demonstrated its safety and comparable side effects to U.S. FDA-approved products. Moving forward, a three-year clinical trial will be conducted to validate its effectiveness and safety for real-world applications. This initiative will enhance patient access to high-quality treatments while positioning Thailand as a key player in developing medical innovations that meet international standards.
Associate Professor Dr. Toemsak Srikhirin, Director of the National Metal and Materials Technology Center (MTEC), stated that lifestyle and work habits among Thais have contributed to a rising prevalence of spinal conditions, increasing the need for spinal fusion surgery. However, this procedure comes with limitations, including potential complications and extended recovery periods.
To address these challenges, MTEC-NSTDA developed OSSICURE Bone Graft, an innovative implantable medical device designed to reduce reliance on autografts, thereby enhancing treatment accessibility and minimizing complication risks. The development process has been carried out in collaboration with medical professionals and the Thai Food and Drug Administration (FDA) to ensure the safety and regulatory compliance of the product.
Furthermore, this innovation holds significant potential for positively impacting Thailand’s public health system, economy, and society, reinforcing the country’s capabilities in advanced medical technology development.
Dr. Sombun Sahasittiwat, Deputy Executive Director of the National Science and Technology Development Agency (NSTDA), stated that NSTDA is committed to developing research with real-world applications through collaborations with key partners, such as the Faculty of Medicine Siriraj Hospital, Mahidol University, which has been a research partner since 2000. This collaboration has led to several significant achievements, including the development of a dengue vaccine and a dengue serotyping test kit, a shrimp allergy test kit, human genetics research, fundamental immunology studies, and advancements in Precision Medicine under Genomics Thailand.
The partnership has been further strengthened through the MU-NSTDA Research Consortium, which focuses on commercial, public, and policy-driven research. OSSICURE Bone Graft is a prime example of high-potential innovation that can be scaled up for industrial production and real-world applications, ultimately reinforcing Thailand’s healthcare system and economy.
The collaboration between MTEC-NSTDA and the Faculty of Medicine Siriraj Hospital, Mahidol University, in the clinical testing of OSSICURE Bone Graft marks a significant milestone in advancing medical innovation. This initiative will expand treatment options for patients undergoing spinal surgery, providing a viable alternative to autografts. Beyond reducing the burden of using the patient’s own bone, this innovation also highlights Thailand’s capabilities in developing world-class medical technologies that meet international standards.
