Graftys, a company focused on development and commercialization of orthopaedic biomaterials, has obtained authorisation from its notified body, NSAI (National Standards Authority of Ireland) for European commercialisation for two of its cements (Graftys HBS and Graftys Quickset) for treatment of bone marrow lesions(BML) caused by traumatic injury.
Graftys HBS and Graftys Quickset are highly injectable and resorbable calcium phosphate cements, developed by Graftys and currently commercialised in 23 countries.
Subchondral bone marrow lesions, also known as bone marrow edema, results in loss of bone volume and micro fractures and loss of mechanical strength of the subchondral bone above or below the knee joint, which may cause an inflammatory reaction and damage the articular cartilage.
“When these bone marrow lesions occur in the subchondral condyle or under the tibial plateau, they can create pain and lead to total knee replacement once traditional treatments fail,” said Jean-Marc Ferrier, vice president of clinical and regulatory affairs, Graftys.
“This new surgical treatment, which involves minimally invasive injection of calcium phosphate cement, under radiographic guidance, can provide orthopaedic surgeons with a new and less invasive method of treatment for patients who suffer from this type of subchondral pain. We are very pleased to have obtained approval for this indication in Europe,” said Aurélien Valet, general manager, Graftys.
“This strengthens Graftys’ market position, which now includes four CE approvals in Europe and three FDA 510(k) clearances. Graftys will set up a clinical data registry aiming at demonstrating the efficacy of our products in the treatment of post-traumatic bone marrow lesions.”
Graftys HBS is a calcium phosphate apatitic cement, highly injectable, particularly adapted to minimally invasive approaches. Its proprietary composition includes a resorbable polymer which allows a better injectability and resorbability of the device.
Graftys Quickset, with a similar composition as the Graftys HBS, has a quicker setting time, is very cohesive, and features an improved mechanical resistance in compression.