Amrita Vishwa Vidyapeetham receives CDSCO approval to initiate clinical trial of synthetic jaw bone graft

Amrita Vishwa Vidyapeetham has received a landmark approval from the Central Drugs Standard Control Organization (CDSCO) for conducting pilot clinical trial for a novel bone graft developed jointly by Amrita School of Nanosciences, Amrita School of Medicine and Amrita School of Dentistry, Kochi. The project was funded by the Department of Sciences and Technology, Government of India, in the initial lab phase and then by Biotechnology Industry Research Assistance Council (BIRAC) for the translational large animal testing and regulatory testing phases. The synthetic bone graft, named Nanotex Bone, provides a first-of-its-kind solution in the world for patients who lose part of their lower jaw (mandibular bone) due to cancer, injury, or trauma. The product, patented by Amrita Vishwa Vidyapeetham, also accepts tooth implants, enabling patients to lead a close-to-normal life even after losing a portion of their oral cavity bone. The clinic trial, that entails testing on ten patients, will be conducted at Amrita School of Medicine and Amrita School of Dentistry, Kochi. It is expected to be completed in 2 years. This is the first time that a university in India has innovated a medical product and taken it all the way from lab research to a potentially successful medical application on its own. Said Dr Shantikumar Nair, Dean of Nanosciences, Center for Nanosciences & Molecular Medicine, Amrita Vishwa Vidyapeetham, who is spearheading the Nanotex Bone project:

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