BD Extends Leadership in Advanced Tissue Regeneration Through Continued Clinical Innovation

Rhea-AI Summary

BD (NYSE: BDX) reported that its STANCE clinical trial of GalaFLEX LITE™ Scaffold in breast revision surgery for capsular contracture has surpassed a key enrollment milestone. The study has treated 274 patients across 33 active U.S. sites, triggering the first planned interim analysis. This exceeds 50% of the trial’s maximum planned enrollment, which under the adaptive design is expected to range from 250 to 530 patients.

The prospective, randomized, controlled, multi-center trial compares GalaFLEX LITE™ Scaffold plus implant revision against conventional revision surgery without a matrix or ADM, using a 2:1 randomization. According to BD, STANCE is intended to generate safety and efficacy data to support a potential new breast indication and a future FDA Premarket Approval application for GalaFLEX LITE™ Scaffold, which is based on BD’s poly-4-hydroxybutyrate (P4HB) bioabsorbable soft tissue support platform.

Positive

• 274 patients enrolled and treated across 33 U.S. sites, surpassing first milestone
• STANCE enrollment >50% of maximum 250–530 patients, enabling interim analysis
• 2:1 randomized trial design versus conventional revision surgery without matrix or ADM
• Potential new breast indication aimed to support future FDA PMA for GalaFLEX LITE™
• P4HB platform backed by more than 10 years of clinical use in soft tissue support

Negative

• None.

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STANCE trial surpasses a key enrollment milestone, advancing the clinical evaluation of GalaFLEX LITE™ Scaffold and generating evidence to support its use in breast revision surgery for capsular contracture

FRANKLIN LAKES, N.J., Aug. 27, 2026 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today 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%¹⁻⁵, and when advanced capsular contracture is treated using conventional surgical techniques, the risk of recurrence may be as high as 54%⁶. This varies substantially by surgical technique, patient characteristics and follow-up duration.

"STANCE reflects our commitment to advancing innovation in soft tissue support and expanding the impact of advanced tissue regeneration in areas where patients continue to face significant clinical challenges," said Art Stephen, global R&D Leader of Surgery at BD. "By evaluating GalaFLEX LITE™ Scaffold in breast revision surgery for capsular contracture, we are generating clinical evidence that could help support a new indication while building on the established performance of our P4HB technology platform. We are grateful to the investigators, clinical sites and patients whose participation made this achievement possible."

"Capsular contracture remains a significant challenge in implant-based breast surgery, and robust clinical evidence is needed to advance patient care," said Caroline Glicksman, MD, FACS, MSJ, a board-certified plastic and reconstructive surgeon in Sea Girt, New Jersey, and the study's national principal investigator. "Enrollment has progressed consistently across participating sites, and we look forward to continuing participant follow-up through each scheduled study milestone as the study generates clinical data intended to support an FDA Premarket Approval application for a breast indication for GalaFLEX LITE™ Scaffold."

GalaFLEX LITE™ Scaffold is engineered to conform to the desired anatomical structure and provide strength and stability throughout the wound healing period⁷. It is composed of poly-4-hydroxybutyrate (P4HB), the only bioabsorbable and biologically derived polymer used for soft tissue support. P4HB has more than 10 years of clinical use supporting hernia repair and other plastic and reconstructive procedures where soft tissue weakness or deficiency exists.

STANCE Study
STANCE (NCT05945329) Clinical Trial is an ongoing prospective, randomized, controlled, multi-center study to assess the safety and efficacy of GalaFLEX LITE™ scaffold in revision surgery for reduction of capsular contracture recurrence and/or malposition in implant-based breast augmentation patients versus patients undergoing conventional revision surgery with no supportive matrix or acellular dermal matrix (ADM). Patients will be randomized 2:1 to receive either GalaFLEX LITE™ Scaffold or standard care (no ADM or matrix placement). 

For more information about GalaFLEX LITE™ scaffold, please visit galaflex.bd.com.

About BD
BD is one of the world's largest pure-play medical technology companies with a Purpose of advancing the world of health™ by driving innovation across medical essentials, connected care, biopharma systems and interventional. The company supports those on the frontlines of healthcare by developing transformative technologies, services and solutions that optimize clinical operations and improve care for patients. Operating across the globe, with more than 60,000 employees, BD delivers billions of products annually that have a positive impact on global healthcare. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase clinical efficiency, improve safety and expand access to healthcare. For more information on BD, please visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/, X  @BDandCo or Instagram @becton_dickinson.

References:

1. Bachour, Y., Capsular Contracture in Breast Implant Surgery: Where Are We Now and Where Are We Going? Aesthetic Plast Surg, 2021. 45(3): p. 1328-1337.
2. Brown, T., Plane Change Vs Capsulotomy: A Comparison of Treatments for Capsular Contraction in Breast Augmentation Using the Subfascial Plane. Aesthetic Plast Surg, 2021. 45(3): p. 845-850.
3. Hasan, S., et al., Preliminary Outcomes of Hypochlorous Acid as an Adjunct for Pocket Irrigation in Revision Aesthetic Breast Surgery. Aesthet Surg J, 2021. 41(4): p. NP152-NP158.
4. Calobrace, M.B., et al., Risk Factor Analysis for Capsular Contracture: A 10-Year Sientra Study Using Round, Smooth, and Textured Implants for Breast Augmentation. Plast Reconstr Surg, 2018. 141(4S Sientra Shaped and Round Cohesive Gel Implants): p. 20S-28S.
5. Boyd, C.J., et al., Systematic Review of Capsular Contracture Management Following Breast Augmentation: An Update. Plast Reconstr Surg, 2023.1 Preclinical data on file. Results may not correlate to clinical outcomes.
6. Hidalgo, D.A. and A.L. Weinstein, Surgical Treatment for Capsular Contracture: A New Paradigm and Algorithm. Plast Reconstr Surg, 2020. 146(3): p. 516-525.
7. Preclinical data on file. Results may not correlate to clinical outcomes.
8. Study of GalaFLEX LITE™ Poly-4-Hydroxybutyrate (P4HB) Scaffold in Treatment of Capsular Contracture after Breast Implant Augmentation (STANCE)

Contacts:
Media	Investors
Matt Marcus VP, Public Relations Matt.Marcus@bd.com	Shawn Bevec  SVP, Investor Relations Investor_Relations@bd.com

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SOURCE BD (Becton, Dickinson and Company)

FAQ

What milestone did BD (NYSE: BDX) announce for the STANCE trial of GalaFLEX LITE Scaffold in August 2026?

BD announced that the STANCE trial reached its first enrollment milestone with 274 patients treated. According to BD, this enrollment across 33 active U.S. sites surpasses 50% of the trial’s maximum planned enrollment and triggers the first planned interim analysis under the adaptive design.

How many patients will be enrolled in BD’s STANCE trial evaluating GalaFLEX LITE LITE Scaffold for capsular contracture?

The STANCE trial is expected to enroll between 250 and 530 patients under its adaptive design. According to BD, surpassing 274 treated patients places enrollment beyond 50% of this maximum range and allows the study to proceed to its first preplanned interim analysis.

What is the design of BD’s STANCE clinical trial for GalaFLEX LITE Scaffold in breast revision surgery?

STANCE is a prospective, randomized, controlled, multi-center trial in implant-based breast augmentation revision surgery. According to BD, patients are randomized 2:1 to receive either GalaFLEX LITE Scaffold or standard care without acellular dermal matrix or other supportive matrix, assessing safety and efficacy for reducing capsular contracture recurrence.

How is BD’s GalaFLEX LITE Scaffold used in treating capsular contracture after breast implant augmentation?

GalaFLEX LITE Scaffold is placed to conform to desired breast anatomy and provide soft tissue support. According to BD, it is composed of bioabsorbable poly-4-hydroxybutyrate (P4HB), designed to deliver strength and stability throughout wound healing in revision surgery for capsular contracture and malposition.

What regulatory goal does BD have for GalaFLEX LITE Scaffold based on the STANCE trial results?

BD intends to use STANCE clinical data to support an FDA Premarket Approval application for a breast indication. According to BD, ongoing enrollment and follow-up in STANCE are designed to provide safety and efficacy evidence for GalaFLEX LITE Scaffold in capsular contracture revision surgery.

Why is BD focusing on capsular contracture with its STANCE trial and GalaFLEX LITE Scaffold?

Capsular contracture is described as the most frequent complication of implant-based breast surgery, with notable recurrence risks. According to BD, STANCE aims to generate robust clinical evidence to improve soft tissue support and potentially reduce recurrence compared with conventional revision techniques without supportive matrices.