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The company sponsored a pivotal, blinded multi-center clinical trial (NCT06404372) to assess the safety and effectiveness of the Demetech Barbed PDO Suture for temporary treatment of midface wrinkles. The study enrolled 57 subjects and evaluated wrinkle improvement over 12 months using the Lemperle Classification Facial Wrinkle Scale. Primary endpoints included adverse event rates and significant wrinkle reduction at 6 months; secondary endpoints focused on longer-term results and patient satisfaction. The trial has been completed.
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