Amrita Vishwa Vidyapeetham, a research-intensive private university in India, has created Nanotex Bone, a synthetic bone graft. The invention is a world-first solution for patients who have lost a portion of their lower jaw (mandibular bone) due to cancer, injury, or trauma.
The product has been patented and approved for clinical trials, according to a University news release. The trial will take place over a two-year period at Amrita School of Medicine and Amrita School of Dentistry in Kochi.
Several medical students were involved in the Nanotex bone graft project at various stages of development, including design, in-vitro studies, small and large animal studies, regulatory and validation studies, and good manufacturing practice (GMP) in production.
The Nanotex graft is significant because oral cavity cancer and its associated mortality rates are on the rise. Every year, 135,929 new cases of oral cavity cancer are diagnosed, with an 8.8 percent mortality rate. According to the International Agency for Research on Cancer (IARC), the number of cases of oral cancer in India is expected to exceed 1.7 million by 2035 due to increased tobacco consumption.
Furthermore, road traffic accidents are common in India, frequently resulting in facial disfigurement and trauma, with approximately 50 percent of victims requiring facial reconstruction surgery.
Dr. Subramania Iyer, professor and chairman of plastic and reconstructive surgery, and head and neck surgery at Amrita School of Medicine, said, “The development of Nanotex bone graft and bringing it up to clinical trial was a journey that took ten years. The product, which can be used for mandible augmentation, will be immensely helpful for 50-60 percent of patients with jaw cancer.”
“It will also be tremendously useful for patients of oral cancer, which is responsible for 25 percent of all cancer-related deaths in India, as well as for road accident victims who require facial reconstruction due to orofacial trauma. The method will not add any significant cost to treatment of patients but immensely improve their quality of life.”
The graft was developed jointly by Amrita School of Nanosciences, Amrita School of Medicine, and Amrita School of Dentistry, Kochi. The initial laboratory phase was funded by the Government of India's Department of Sciences and Technology, and the translational large animal testing and regular testing phases were funded by the Biotechnology Industry Research Assistance Council (BIRAC).
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