Collagen Solutions plc (LON:COS), the developer and manufacturer of medical grade collagen components for use in regenerative medicine, medical devices and in-vitro diagnostics, announced today that the final patient has been assessed in the eight-year extension clinical study of 15 patients who received a ChondroMimetic® implant as an osteochondral scaffold for the repair of cartilage defects in the knee.
· Clinical trial enrolled 17 patients in 2009-2010; six-month results demonstrated safety and improved clinical outcomes
· Original six-month MRI data analysed retrospectively in 2017 using quantitative MRI techniques indicated early improved structural defect repair
· 15 patients enrolled between June and September 2017 for prospective eight-year extension study
· Full clinical and quantitative MRI data analysis ongoing
The 15 patients were part of the original six-month safety and early clinical outcomes study of 17 patients in 2009-2010, which showed filling of the original defect and early signs of integration with healthy cartilage. The current extension phase of the study with these same patients uses enhanced MRI imaging techniques to permit longitudinal assessment of durability of cartilage repair and the integration of the ChondroMimetic implant, as well as clinical outcomes.
A retrospective analysis of the original MRI images was recently performed using T2 mapping, an imaging technique that is used to quantify the differences between native and implanted cartilage tissue. The analysis indicated that the ChondroMimetic scaffold was virtually indistinguishable from surrounding cartilage at six months following surgery. This technique and other MRI analyses will be replicated for the long-term study to assess the sustainability and completeness of bone and cartilage defect filling, as well as cartilage quality.
The “Last Patient Out” milestone has now been completed and the data is being compiled and audited, in line with the Company’s previously announced timelines. Following the completion of the Clinical Study Report, Collagen Solutions will submit it as part of a package to the regulatory authorities for approval and the re-establishment of the CE mark targeting commercialisation outside the US in mid-2018.
The Company has made a presentation available regarding this study update on its website at:
Jamal Rushdy, CEO of Collagen Solutions said: “We are pleased with the progress of the long-term ChondroMimetic study and are enthusiastic about the potential for this product to enable surgeons to treat patients affected by early arthritis and cartilage defects with a simple, proven, and cost-effective treatment. To our knowledge, ChondroMimetic will be the only arthroscopically applied cartilage scaffold backed by long-term evidence, significantly differentiating it from competing therapies. This study extension is a fundamental step forward in our programme for developing ChondroMimetic as a product which has the potential to address 450,000 annual cartilage procedures and provide access to a potential US $500M-$1B market opportunity.”
About Collagen Solutions:
Collagen Solutions Plc is a global supplier, developer, and manufacturer of medical grade collagen, tissues, and related medical devices and components for use in regenerative medicine, medical devices and in-vitro diagnostics and research. The Company is also expanding its range of biomaterials-based finished medical devices based on its internal and acquired intellectual property for commercialisation with partners via licensing and distribution arrangements, including ChondroMimetic. The Company’s products are used in a wide variety of applications including orthopaedics, cardiovascular, dental, plastic surgery, wound healing, neurology and urology.