Becton, Dickinson and Company (NYSE: BDX) announced that its STANCE clinical trial, evaluating GalaFLEX LITE™ Scaffold in breast revision surgery for capsular contracture, has surpassed its first enrollment milestone, with 274 patients treated across 33 active U.S. sites.

The milestone triggers the trial's first planned interim analysis and places enrollment beyond 50% of the study's maximum planned total. The adaptive trial design anticipates between 250 and 530 patients in total.

The STANCE trial (NCT05945329) is a prospective, randomized, controlled, multi-center study assessing the safety and efficacy of GalaFLEX LITE™ Scaffold in revision surgery for reduction of capsular contracture recurrence and implant malposition. Patients are randomized 2:1 to receive either the scaffold or standard care, which includes no supportive matrix or acellular dermal matrix placement.

Capsular contracture occurs when scar tissue forming around a breast implant becomes unusually hard, potentially causing pain and anatomical displacement. Published estimates place overall incidence at 10% to 20%, and recurrence rates following conventional surgical treatment may reach as high as 54%, according to cited literature.

GalaFLEX LITE™ Scaffold is composed of poly-4-hydroxybutyrate (P4HB), a bioabsorbable and biologically derived polymer. According to BD, P4HB has more than 10 years of clinical use in hernia repair and other plastic and reconstructive procedures.

Caroline Glicksman, MD, the study's national principal investigator, said the trial is generating clinical data "intended to support an FDA Premarket Approval application for a breast indication for GalaFLEX LITE™ Scaffold."

BD is headquartered in Franklin Lakes, N.J., and employs more than 60,000 people globally. The information in this article is based on a press release issued by the company.