Tissue Regenix ((GB:TRX)) announced an update on their ongoing clinical study.
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Study Overview: The OrthoPureXT Multiligament PMCF Study, officially titled ‘Post Market Clinical Follow-Up of OrthoPureXT for the Treatment of Multiligament Injured Knee: a Case Series,’ aims to monitor residual risks and ensure continued clinical evaluation of the OrthoPureXT device’s safety and performance in multiligament knee reconstructions. This study is significant as it seeks to identify any new or unexpected risks associated with the device in a post-market setting.
Intervention/Treatment: The study tests the OrthoPure XT, a device designed for knee ligament reconstruction to restore function and stability. It is used in various anatomical locations, including the PCL, ACL, MCL, and LCL, with multiple sizes available for different reconstruction needs.
Study Design: This interventional study employs a single-group model where participants with multiligament knee injuries are evenly distributed across different ligament reconstruction options. There is no masking involved, and the primary purpose is treatment-focused.
Study Timeline: The study began on November 16, 2022, with recruitment currently ongoing. The last update was submitted on April 14, 2025. These dates are crucial as they indicate the study’s progression and current status.
Market Implications: The ongoing evaluation of OrthoPureXT could influence Tissue Regenix’s stock performance positively if results demonstrate safety and efficacy, enhancing investor confidence. The study’s outcome may also impact the competitive landscape, particularly if the device proves superior to existing solutions.
The study is ongoing, with further details available on the ClinicalTrials portal.