Global Finance News
27 Aug 2026, 16:46
BD Advances GalaFLEX LITE Trial for Breast Revision Surgery
Becton, Dickinson and Company (NYSE: BDX) announced a key clinical milestone for its GalaFLEX LITE Scaffold, strengthening its push into advanced tissue regeneration.
The STANCE trial has now treated 274 patients across 33 U.S. sites, surpassing 50% of its maximum planned enrollment and triggering the study’s first interim analysis.
The randomized trial is evaluating whether GalaFLEX LITE can reduce recurrence of capsular contracture and implant malposition following breast revision surgery compared with conventional treatment.
Capsular contracture is one of the most common complications of implant-based breast surgery, with reported incidence of 10%–20% and recurrence after conventional revision procedures potentially reaching 54%.
The study is intended to generate clinical evidence supporting an FDA Premarket Approval application for a breast indication. GalaFLEX LITE uses BD’s bioabsorbable P4HB technology, which has more than a decade of clinical use in soft-tissue support applications.
For BD, a successful trial could expand GalaFLEX LITE into a sizable new indication within plastic and reconstructive surgery and strengthen the company's position in advanced tissue regeneration.
Becton, Dickinson and Company (NYSE: BDX) announced a key clinical milestone for its GalaFLEX LITE Scaffold, strengthening its push into advanced tissue regeneration.
The STANCE trial has now treated 274 patients across 33 U.S. sites, surpassing 50% of its maximum planned enrollment and triggering the study’s first interim analysis.
The randomized trial is evaluating whether GalaFLEX LITE can reduce recurrence of capsular contracture and implant malposition following breast revision surgery compared with conventional treatment.
Capsular contracture is one of the most common complications of implant-based breast surgery, with reported incidence of 10%–20% and recurrence after conventional revision procedures potentially reaching 54%.
The study is intended to generate clinical evidence supporting an FDA Premarket Approval application for a breast indication. GalaFLEX LITE uses BD’s bioabsorbable P4HB technology, which has more than a decade of clinical use in soft-tissue support applications.
For BD, a successful trial could expand GalaFLEX LITE into a sizable new indication within plastic and reconstructive surgery and strengthen the company's position in advanced tissue regeneration.
