OrthoSera GmbH, an orthobiologics company developing serum-based solutions for musculoskeletal indications, announced that a double-blind, controlled study with BoneAlbumin™, the company’s first marketed product, has been accepted for publication in International Orthopaedics. The technology is covered by a patent, which has recently been granted by the European Patent Office and is already issued in the US.
The technology is based on the proprietary serum albumin coating of bone allografts, a fully human bone substitute that has shown strong stem cell induction capacity. This feature is unique among cell-free bone grafts as this is the only off-the-shelf tissue product that is capable of further enhancing the innate bone inducing ability of allografts. The current study has proven with high statistical significance that BoneAlbumin™ implantation not only results in better remodelling on CT images but significantly reduced pain at the implantation site even six months after surgery. In the sports medicine field, anterior cruciate ligament (ACL) replacement with patellar bone-tendon-bone (BTB) autograft is the first choice of implant by many surgeons, especially for athletes with high demands on the knee joint. Donor-site pain is the major side-effect of BTB harvesting and the current study has shown that it can be avoided by a novel, off-the-shelf bone graft implantation. This is a significant step forward in bone tissue engineering as it achieves better implantation abilities without the cost or complexity of cell-based therapies.
BoneAlbumin™ is already in use in the European dental market with almost 1,000 successful implantations since its introduction in late 2015 and additional clinical indications being investigated by key opinion leaders in orthopaedics.