Becton, Dickinson(US:BDX) Prnewswire·2025-03-20 10:50Core Insights - BD (Becton, Dickinson and Company) has initiated a clinical trial for the GalaFLEX LITE™ Scaffold aimed at reducing capsular contracture recurrence during breast revision surgery, marking a significant step towards obtaining FDA Premarket Approval [1][3][5] Company Overview - BD is a leading global medical technology company focused on improving medical discovery, diagnostics, and care delivery, with a commitment to enhancing patient outcomes through innovative technologies [8] Clinical Trial Details - The STANCE study is a multi-center, randomized, controlled trial designed to evaluate the safety and efficacy of the GalaFLEX LITE™ Scaffold in breast implant revision surgery, with an enrollment target of at least 250 patients across 40 sites [5][7] - Capsular contracture is a common complication in implant-based breast surgery, with an incidence rate of 10% to 20%, and conventional surgical techniques have a recurrence risk as high as 54% [2][5] Product Information - The GalaFLEX LITE™ Scaffold is made from Poly-4-Hydroxybutyrate (P4HB), a fully absorbable polymer with over 10 years of clinical use in various surgical applications, designed to provide immediate strength and stability during the wound healing process [3][4] Expert Commentary - Surgeons involved in the trial express optimism about the potential benefits of the GalaFLEX LITE™ Scaffold in improving patient outcomes and addressing a critical complication in breast surgery [4][5]