MONTPELLIER, France--(BUSINESS WIRE)--Analysis of a major subgroup of patients undergoing a first Total Knee Replacement (TKR), representing over 70% of the trial population (108 out of 151), revealed the following benefits when comparing patients treated with F14/mdc-CWM (n=51) to those in the control group (n=57)1:
- 70% reduction in the number of opioid users at 3 months post-surgery,
- 28% reduction in the total quantity of opioids consumed during the first 3 months post-surgery,
- Lower daily knee pain over the endpoints of 3 and 7 days, 2 and 6 weeks, and 3 months post-surgery,
- Range of motion (ROM) milestone (100 degrees) achieved significantly faster,
- Significant improvements across multiple, independent assessments of pain, inflammation and function.
The analysis of this large subgroup of patients undergoing their first TKR revealed a consistently greater treatment effect compared to the overall study population which also included patients receiving a second TKR.2
This subgroup of patients will be the primary focus of future clinical development, planned for 2025, provided FDA agreement.
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1 Source: F14 Clinical Phase 3 Study (100-CIP02; 2022-2024); Data on file. Arthritis Innovation Corporation - Toronto, Canada; ClinicalTrials.govID NCT05603832
2 Results presented in May 2024; www.medincell.com/wp-content/uploads/2024/05/PR_Medincell_CWM_14052024_EN.pdf
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