BOSTON, Jan 24 (Bernama-BUSINESS WIRE) — ReLive is proud to announce that the Health Sciences Authority (HSA), Singapore’s highest health authority, has granted New Drug Application (NDA) approval for SpheChon 10-70 spheroids/cm² in December 2023, marking the country’s first cell therapy product for cartilage repair in its history. This approval is a testament to ReLive’s commitment to advancing regenerative cell therapies and marks a significant step in expanding our global reach.
Based on the approval, the indication comprises the repair of symptomatic articular cartilage defects of the femoral condyle and the patella of the knee (International Cartilage Regeneration & Joint Preservation Society [ICRS] grade III or IV) with defect sizes 1 cm² to 10 cm² in adults and adolescents with closed epiphyseal growth plate in the affected joint.