Locate Bio’s Chondro3 Granted FDA Breakthrough Device Designation

Locate Bio’s Chondro3 Granted FDA Breakthrough Device Designation

Novel cartilage regenerative product, Chondro3 is a biomimetic graft for osteochondral lesions

The Company’s second FDA Breakthrough Device designation granted in 2021

Locate Bio, an orthobiologics focused regenerative medicine company, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to Chondro3, currently in development as a biomimetic graft for osteochondral lesions. The FDA Breakthrough Device Program is designed to accelerate patient access to promising technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.

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 lack of intrinsic tissue healing capacity of cartilage leaves many people on the path to degenerative osteoarthritis, chronic pain and potential total knee replacement surgery[i], all of which place a significant burden on the world’s healthcare systems. It is estimated that over 60% of the 1 million knee arthroscopies performed in the U.S. each year involves a chondral lesion[ii], representing a potential market opportunity in excess of $1bn[iii].

Chondro3 has been designed to be a truly regenerative product that has significant potential to address this growing unmet medical need. It is a three layered, proprietary collagen-based biodegradable matrix that can be delivered in 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 lesion, supporting the biomimetic repair of both cartilage (chondrogenesis) and bone (osteogenesis). Chondro3 has been shown in peer-reviewed, pre-clinical studies that it can regenerate long-lasting hyaline cartilage[iv], which is critical to long term outcomes. 

John von Benecke, CEO of Locate Bio, 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.”

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 of hundreds of thousands of patients suffering from osteochondral lesions.”

In January 2021, Locate Bio was granted a Breakthrough Device designation from the FDA for its investigational treatment for chronic osteomyelitis, CognitOss. CognitOss is a drug-device combination product for the treatment of chronic infections within bone. It has a unique antibiotic release profile, targeting both improvements in the elimination of infection, and the regeneration of bone at the infection site. These Breakthrough Device designations underscore Locate Bio’s innovative product offerings focused on improving patient lives.

[i] Smith, G. D., Knutsen, G. & Richardson, J. B. & of Orthopaedics Robert Jones, P. A clinical review of cartilage repair techniques. J. Bone Jt. Surg. 87, 445–449 (2005).

[ii] Widuchowski W., Widuchowski J., Trzaska T. Articular cartilage defects: Study of 25,124 knee arthroscopies. Knee. 2007;14:177–182

[iii] Company estimates

[iv] Levingstone, Tanya J., et al. “Cell-Free Multi-Layered Collagen-Based Scaffolds Demonstrate Layer Specific Regeneration of Functional Osteochondral Tissue in Caprine Joints.” Biomaterials, vol. 87, 1 May 2016, pp. 69–81. https://doi.org/10.1016/j.biomaterials.2016.02.006

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Tim Stamper

Senior Consultant | Strategic Communications

FTI Consulting

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Tim.Stamper@fticonsulting.com

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