Chondro3 has been recognised by the FDA Breakthrough Devices Program, which aims to improve patient access to new technologies
Chondro3, a novel cartilage regeneration product from UK biotech firm Locate Bio, has gained breakthrough device designation from the US FDA.
The product is currently in development as a biomimetic graft for repairing damage to the cartilage and underlying bone in a joint – also known as osteochondral lesions.
According to Locate Bio, Chondro3 is a collagen-based biodegradable matrix that can be delivered to patients via a single procedure in an out-patient setting, and at an affordable price.
It is designed to provide a scaffold for cellular and tissue in-growth, and osteochondral defect repair, at the site of a lesion, supporting the biomimetic repair of both cartilage and bone.
Locate Bio also claims that, in peer-reviewed, pre-clinical studies, Chondro3 has proved effective in regenerating long-lasting hyaline cartilage – which is critical to long-term outcomes.
In receiving FDA breakthrough device designation – which aims to accelerate patient access to promising technologies – the biomimetic graft has been identified as having the potential to meet an unmet need, and provide more effective treatment for a life-threatening or irreversibly debilitating condition.
Chondro3 is the second Locate Bio product to be identified by the FDA Breakthrough Devices Program in 2021, with its CognitOss drug-device combination product for the treatment of chronic infections within bones also being selected last month.
Keith Valentine, non-executive chair of Locate Bio, said: “This is another important milestone for Locate Bio.
“There is a significant unmet need for effective new orthobiologic products that improve the options available to surgeons in this area.
“We believe Chrondro3 is a very exciting product that has significant potential to improve the outcomes for hundreds of thousands of patients suffering from osteochondral lesions.”
Why is Chondro3 needed?
Osteochondral defects commonly 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, and the lack of intrinsic tissue healing capacity of cartilage leaves many people on the path to degenerative osteoarthritis, chronic pain and, potentially, total knee replacement surgery.
All of these consequences place a significant burden on the world’s healthcare systems.
Locate Bio estimates that more than 60% of the one million knee arthroscopies performed in the US each year involve a chondral lesion – representing a potential market opportunity in excess of $1bn.
The company’s CEO John von Benecke said: “We are delighted to have been granted our second breakthrough device designation from the FDA – this time for Chondro3, our exciting biomimetic graft for osteochondral lesions.
“There is an enduring unmet need for a cost-effective regenerative treatment, and we are proud that the FDA has recognised the potential of Chondro3 to address this serious public health issue.
“Having received two breakthrough device designations this year, we are gaining real momentum towards achieving our ambition of building a world-leading orthobiologics business that addresses clear unmet needs of both surgeons and patients.
“We look forward to further progressing Chondro3 through the next stages of development to regulatory approval, and to discussing opportunities with potential partners who share our vision for this product.”