KUALA LUMPUR, Jan 24 (Bernama) -- ReLive announced the Singapore’s Health Sciences Authority (HSA) has granted New Drug Application (NDA) approval for SpheChon 10-70 spheroids/square centimetre (cm²) in December 2023, marking the country’s first cell therapy product for cartilage repair in its history.
According to a statement, this approval is a testament to ReLive's commitment to advancing regenerative cell therapies and marks a significant step in expanding its global reach.
ReLive Chief Executive Officer, Dr Xing Zhao said the approval in Singapore signified ReLive's growing influence and commitment to addressing unmet needs in the areas of orthopaedic sports medicine as well as plastic and reconstructive surgery in Asia.
“This achievement aligns with our strategic vision of expanding our footprint in key markets and underscores our commitment to transforming patient care on a global scale,” he said.
Based on the approval, the indication comprises the repair of symptomatic articular cartilage defects of the femoral condyle and the patella of the knee with defect sizes one cm² to 10 cm² in adults and adolescents with closed epiphyseal growth plate in the affected joint.
SpheChon represents a major advancement in cell therapy for cartilage repair, offering new hope and enhanced treatment options by using the patients’ own cells to regain an active life.
This approval by HSA reflects ReLive’s dedication to upholding the highest standards of safety, efficacy, and quality in its innovative treatment solutions.
Founded in 2021, ReLive strives to make a lasting impact on the field of biotechnology and cell therapy and revolutionise the treatment of orthopaedic and reconstructive conditions.
-- BERNAMA
