Released: Friday 7th July 2017

Collagen Solutions plc (AIM: COS), the developer and manufacturer of medical grade collagen components for use in regenerative medicine, medical devices and in-vitro diagnostics, announces the commencement of patient enrolment into an open label extension study as part of the clinical development programme for ChondroMimetic®, an osteochondral scaffold for the repair of cartilage defects in the knee. CE-marking for ChondroMimetic® was previously achieved prior to the Company’s acquisition of the product and related IP, and this follow-up clinical study is a step towards reestablishing that CE-mark certification.

This extension study will supplement the original prospective safety and functional improvement data from 17 patients gathered in 2009 which supported CE Mark regulatory approval.  Here, patient reported pain and functional scores, in addition to an advanced MRI technique called T2 mapping, will assess long-term outcomes in the original study patients, 7-to-8-years after their ChondroMimetic® treatment.  Three-dimensional T2 MRI uses a non-invasive but highly accurate quantitative evaluation of the quality of cartilage, and with longitudinal MRI scans, can establish similarities between native and repaired cartilage over time.  A retrospective case study of several ChondroMimetic® patients was already conducted and indicated that even at 6 months post-treatment, ChondroMimetic® repair tissue was nearly indistinguishable from surrounding cartilage by T2 mapping.

To date, 15 of the original 17 patients have confirmed enrolment to the extension study and initial clinical visits have already been initiated.  Collagen Solutions is targeting study completion before the end of the year.

Jamal Rushdy, CEO of Collagen Solutions said: “We are excited to begin the clinical assessment of long-term scaffold performance in patients who received the ChondroMimetic® implant. To our knowledge, ChondroMimetic® will be the only known, ‘unpartnered’ product with such long-term clinical evidence, significantly differentiating it from competing therapies. This extension study represents a critical step forward in our ChondroMimetic® development programme, which has the potential to address 450,000 annual cartilage procedures and provide access to a US $500M-$1B market opportunity via a novel, proprietary technology.”

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.

Enquiries: