CO.DON AG: 5-year results of phase III clinical trial published

Teltow / Leipzig, 01 November 2022 – The renowned scientific journal "Knee Surgery, Sports Traumatology, Arthroscopy" published the 5-year results of the multicentric, prospective, randomised, controlled phase III clinical trial co.wisi (cod16 HS13) with the autologous chondrocyte implants offered by CO.DON AG.

The phase III clinical trial examined the safety and efficacy of matrix-associated autologous chondrocyte implantation (ACI-M) with spheroids compared to the alternative treatment method of microfracturing in patients with smaller cartilage defects (1 to 4 cm²).

The primary aim of the study was to evaluate data from the Knee Injury and Osteoarthritis Outcome Score (KOOS), a well-established instrument that records patients' self-assessments of any restrictions in their lives due to knee cartilage defects. The non-inferiority of ACI-M to the comparative therapy of microfracturing was confirmed for the overall KOOS and all 5 subscores. Compared with the results of the alternative therapy, better clinical results were observed in the areas of “activities of daily living”, “quality of life” and “sport and recreation”. This underlines the importance of ACI-M for young and active patients.

Medical imaging technology (MRT) also showed an improvement in patients who had been treated with autologous chondrocyte implants. Furthermore, clinical improvement was observed in both the modified Lysholm and IKDC assessments. These are two additional questionnaires to assess the knee function.

The study results reaffirm the safety and efficacy of ACI-M with spheroids at a mid to long-term follow-up. The study can be viewed at: https://rdcu.be/cX3kN

CO.DON AG develops, produces and distributes autologous cell therapies for the minimally invasive repair of cartilage defects. The product being marketed is a cell therapy product for the minimally invasive treatment of cartilage damage in the knee joint that uses only the patient's own cartilage cells ("autologous chondrocytes"). CO.DON's method is currently used in over 200 clinics in Germany and more than 17,000 patients have already been treated. In July 2017 CO.DON AG received central EU marketing authorisation for this product, followed by the marketing authorization for Switzerland in March 2019. At the Leipzig site, CO.DON has built one of the largest facilities for the production of human cells on an industrial scale for in-house and contract manufacturing. The shares in CO.DON AG are listed on the Frankfurt Stock Exchange (ISIN: DE000A3E5C08). Executive Board: Tilmann Bur.

Further information is available from www.codon.de.

Contact

Matthias Meißner
Director Corporate Communications

Investor Relations / Public Relations
T: +49 (0)341 99190 330
F: +49 (0)341 99190 309
E: ir@codon.de