BOSTON--(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.
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 our innovative treatment solutions.
Quote from ReLive’s CEO, Dr. Xing Zhao: “The approval in Singapore is more than just a regulatory milestone. It signifies ReLive's growing influence and commitment to addressing unmet needs in the areas of orthopedic sports medicine and 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.”
About ReLive Biotechnologies Ltd.: ReLive is a pioneering global biotechnology company, founded in 2021 by a team of distinguished visionaries and accomplished experts in the fields of tissue engineering, regenerative medicine, and cell therapy. Backed by venture capital, along with the acquisition of CO.DON, ReLive brings together a diverse team of scientists, surgeons, managers, and regulatory experts with extensive and direct experience in biotechnology, to collaborate and develop groundbreaking treatments that improve patient outcomes. Through the ongoing research and development efforts, ReLive strives to make a lasting impact on the field of biotechnology and cell therapy and revolutionize the treatment of orthopedic and reconstructive conditions. ReLive operates across three key locations: Boston (Global Headquarter), Germany and China. For more information, please visit our website www.relivebio.com or contact us via contact@relivebio.com.