Regenerative medicine company Orthocell has announced TGA approval of Ortho-ACI, the company's autologous chondrocyte implantation for cartilage repair and regeneration.
According to the company, the product has previously been approved for sale in Australia pursuant to a TGA issued manufacturing license. TGA approval was required to ensure commercial sale of Ortho-ACI.
The company said TGA approval marks a significant milestone. It enables the commencement of the reimbursement process and also the wider sale and distribution of Ortho-ACI.
It also represents the first cell therapy for cartilage repair to be included on the Australian Register of Therapeutic Goods.
Ortho-ACI is an intervention for symptomatic defects of the articulating cartilage of the joints, predominately the knee and ankle. Damage to articular cartilage can occur through injury or normal wear and tear. When articular cartilage is damaged, it does not repair itself effectively like other tissues and cartilage defects lead to increasing joint pain and impaired mobility, which affects activities of daily living and exercise. These defects present a difficult clinical problem and if left untreated can lead to osteoarthritis.
"Ortho-ACI provides the opportunity for the body to regenerate its own cartilage and provide a functional and durable outcome," said the company.
“The inclusion by the TGA of Ortho-ACI on the ARTG is a significant milestone for the Company and enables the continued pathway towards reimbursement,” said managing director Paul Anderson.