Regenerative orthobiologics company Locate Bio reported on Wednesday the receipt of US Food and Drug Administration (FDA) breakthrough device designation for Chondro3, which is currently in development as a biomimetic graft for osteochondral lesions.

According to the company, osteochondral lesions are a tear or fracture that involves damage to both the cartilage and underlying bone. Osteochondral defects often occur in joints and are most common in the articular cartilage and subchondral bone structures of the knee and ankle. Articular cartilage injuries often occur following an acute traumatic injury or an underlying bone disorder.

The company said Chondro3 is a three layered, proprietary collagen-based biodegradable graft that can be delivered in a single procedure, in an out-patient setting and at an affordable price. It provides a scaffold for cellular and tissue in-growth and osteochondral defect repair at the site of lesion, supporting the biomimetic repair of both cartilage (chondrogenesis) and bone (osteogenesis).

Under the company's peer-reviewed, pre-clinical studies, Chondro3 has shown to regenerate long-lasting hyaline cartilageiv, which is critical to long term outcomes.

For 2021, this is the company's second FDA's breakthrough device designation, which followed the agency's investigational treatment for chronic osteomyelitis, CognitOss.