August 27, 2026- BD announced a significant milestone in its advanced tissue regeneration strategy and expansion efforts with the STANCE clinical trial evaluating GalaFLEX LITE™ Scaffold in breast revision surgery for capsular contracture. The study has reached its first enrollment milestone, with 274 patients treated across 33 active U.S. sites, triggering the first planned interim analysis. This milestone places enrollment beyond 50% of the trial’s maximum planned enrollment, expected to range from 250 to 530 patients under the adaptive design and prespecified criteria.
Implant-based breast surgery is among the most common plastic surgery procedures performed each year in the U.S., and capsular contracture is its most frequent complication. The condition occurs when scar tissue that naturally forms around the implant becomes unusually hard, potentially causing pain and anatomical displacement. Published estimates show overall incidence ranges from 10% to 20%, and when advanced capsular contracture is treated using conventional surgical techniques, the risk of recurrence may be as high as 54%. This varies substantially by surgical technique, patient characteristics and follow-up duration.