NOTTINGHAM, England--(BUSINESS WIRE)--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 surgeryi, 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 lesionii, representing a potential market opportunity in excess of $1bniii.
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 cartilageiv, 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.
About Locate Bio
Locate Bio is an innovative orthobiologics company with a proprietary, regenerative medicine pipeline, delivering exciting orthobiologics products that have great disruptive potential.
Locate Bio’s ambition is to build a world leading, orthobiologics business with a diversified suite of best-in-class technologies that address the performance limitations of existing products and enable orthopaedic surgeons to improve the lives of people suffering from debilitating conditions.
In September 2020, Locate Bio announced the acquisition of multiple late stage complementary orthobiologics assets from Royal College of Surgeons in Ireland (RCSI) University of Medicine and Health Sciences, accelerating its route to market and broadening its orthobiologics pipeline. Locate’s portfolio now includes CertOss, a semi-synthetic graft substitute; CognitOss, the same graft substrate as CertOss but designed to elute antibiotics for the treatment of osteomyelitis; LDGraft a low dose, controlled release rhBMP-2 spinal fusion product intended for the treatment of lower back pain caused by degenerative disc disease; and Chondro3, a three-layer cartilage repair graft. The Company continues to look for partnering opportunities, both in-licencing or out-licencing that would further its aim of providing surgeons with a choice of best-in-class technologies and products that address the current challenges of existing products and meet specific patient driven clinical needs.
Locate Bio is a spin-out from the University of Nottingham. The Company is backed by Mercia Asset Management PLC.
To learn more visit: https://www.locatebio.com/
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