BD Announces Milestone in Clinical Trial for Use of Bioabsorbable GalaFLEX LITE™ Scaffold in Breast Implant Revision Surgery
BD (NYSE: BDX) has initiated a significant clinical trial for its GalaFLEX LITE™ Scaffold in breast implant revision surgery. The first patient has been treated in an IDE clinical trial aimed at obtaining FDA Premarket Approval for reducing capsular contracture recurrence.
The STANCE study will evaluate the scaffold's effectiveness in decreasing capsular contracture, a common complication affecting 10-20% of breast implant surgeries. The trial targets enrollment of at least 250 patients across 40 investigative sites, with patients randomized 2:1 to receive either GalaFLEX LITE™ Scaffold or standard care.
The scaffold, made from P4HB (a bioabsorbable polymer), is designed to provide immediate strength during healing. Five medical centers are currently enrolling patients, marking BD's advancement in biomaterial science for tissue reconstruction.
BD (NYSE: BDX) ha avviato un importante studio clinico per il suo GalaFLEX LITE™ Scaffold nella chirurgia di revisione degli impianti mammari. Il primo paziente è stato trattato in uno studio clinico IDE volto a ottenere l'approvazione pre-commercializzazione della FDA per ridurre la ricorrenza della contrattura capsulare.
Lo studio STANCE valuterà l'efficacia dello scaffold nel ridurre la contrattura capsulare, una complicazione comune che colpisce il 10-20% degli interventi chirurgici di impianto mammario. Lo studio mira a reclutare almeno 250 pazienti in 40 siti di indagine, con pazienti randomizzati 2:1 per ricevere il GalaFLEX LITE™ Scaffold o le cure standard.
Lo scaffold, realizzato in P4HB (un polimero bioassorbibile), è progettato per fornire resistenza immediata durante il processo di guarigione. Cinque centri medici stanno attualmente reclutando pazienti, segnando il progresso di BD nella scienza dei biomateriali per la ricostruzione dei tessuti.
BD (NYSE: BDX) ha iniciado un importante ensayo clínico para su GalaFLEX LITE™ Scaffold en cirugía de revisión de implantes mamarios. El primer paciente ha sido tratado en un ensayo clínico IDE destinado a obtener la aprobación previa a la comercialización de la FDA para reducir la recurrencia de la contractura capsular.
El estudio STANCE evaluará la efectividad del scaffold en la disminución de la contractura capsular, una complicación común que afecta al 10-20% de las cirugías de implantes mamarios. El ensayo tiene como objetivo reclutar al menos 250 pacientes en 40 sitios de investigación, con pacientes aleatorizados 2:1 para recibir ya sea el GalaFLEX LITE™ Scaffold o el tratamiento estándar.
El scaffold, hecho de P4HB (un polímero bioabsorbible), está diseñado para proporcionar resistencia inmediata durante la curación. Actualmente, cinco centros médicos están reclutando pacientes, marcando el avance de BD en la ciencia de biomateriales para la reconstrucción de tejidos.
BD (NYSE: BDX)는 유방 임플란트 재수술을 위한 GalaFLEX LITE™ Scaffold의 중요한 임상 시험을 시작했습니다. 첫 번째 환자가 캡슐 구축 재발을 줄이기 위한 FDA 사전 시장 승인을 얻기 위한 IDE 임상 시험에서 치료를 받았습니다.
STANCE 연구는 캡슐 구축을 감소시키는 스캐폴드의 효과를 평가할 것입니다. 캡슐 구축은 유방 임플란트 수술의 10-20%에 영향을 미치는 일반적인 합병증입니다. 이 시험은 40개의 조사 사이트에서 최소 250명의 환자를 모집하는 것을 목표로 하며, 환자는 2:1 비율로 GalaFLEX LITE™ Scaffold 또는 표준 치료를 받도록 무작위 배정됩니다.
스캐폴드는 P4HB(생분해성 폴리머)로 만들어져 있으며, 치유 과정에서 즉각적인 강도를 제공하도록 설계되었습니다. 현재 5개의 의료 센터가 환자를 모집하고 있으며, 이는 조직 재건을 위한 바이오 소재 과학에서 BD의 발전을 나타냅니다.
BD (NYSE: BDX) a lancé un essai clinique significatif pour son GalaFLEX LITE™ Scaffold dans la chirurgie de révision des implants mammaires. Le premier patient a été traité dans un essai clinique IDE visant à obtenir l'approbation préalable à la commercialisation de la FDA pour réduire la récurrence de la contracture capsulaire.
L'étude STANCE évaluera l'efficacité du scaffold dans la réduction de la contracture capsulaire, une complication courante touchant 10-20% des chirurgies d'implants mammaires. L'essai vise à recruter au moins 250 patients dans 40 sites d'investigation, avec des patients randomisés dans un rapport de 2:1 pour recevoir soit le GalaFLEX LITE™ Scaffold, soit les soins standard.
Le scaffold, fabriqué à partir de P4HB (un polymère bioabsorbable), est conçu pour fournir une résistance immédiate pendant la guérison. Cinq centres médicaux recrutent actuellement des patients, marquant les avancées de BD dans la science des biomatériaux pour la reconstruction des tissus.
BD (NYSE: BDX) hat eine bedeutende klinische Studie für sein GalaFLEX LITE™ Scaffold zur Revision von Brustimplantaten initiiert. Der erste Patient wurde in einer IDE-Studie behandelt, die darauf abzielt, die FDA-Vorabgenehmigung zur Reduzierung der Wiederkehr von Kapselkontrakturen zu erhalten.
Die STANCE-Studie wird die Wirksamkeit des Scaffolds bei der Verringerung von Kapselkontrakturen bewerten, einer häufigen Komplikation, die 10-20% der Brustimplantatoperationen betrifft. Die Studie zielt darauf ab, mindestens 250 Patienten an 40 Prüfzentren zu rekrutieren, wobei die Patienten im Verhältnis 2:1 entweder das GalaFLEX LITE™ Scaffold oder die Standardbehandlung erhalten.
Das Scaffold, das aus P4HB (einem bioabbaubaren Polymer) besteht, ist so konzipiert, dass es während des Heilungsprozesses sofortige Stabilität bietet. Derzeit rekrutieren fünf medizinische Zentren Patienten, was den Fortschritt von BD in der Biomaterialwissenschaft für die Gewebereparatur markiert.
- First patient treated in IDE trial, advancing towards FDA Premarket Approval
- Addresses large market opportunity with 10-20% complication rate in breast implants
- Product has 10+ years of clinical use history in related applications
- Long regulatory pathway ahead with extensive trial requirements
- High patient enrollment needed (250+) could extend trial timeline
Insights
BD's initiation of the STANCE clinical trial for GalaFLEX LITE™ Scaffold represents a strategic expansion of their existing biomaterial technology into the high-value breast implant market. The trial addresses capsular contracture (CC) - a significant unmet clinical need affecting 10-20% of breast implant patients with recurrence rates as high as 54% following conventional revision techniques.
The P4HB technology underlying GalaFLEX LITE™ has established safety data with over 10 years of clinical use in other applications, providing a solid foundation for this indication expansion. This isn't merely a new product development but a logical extension of proven technology into a high-incidence complication area.
The robust trial design (250+ patients across 40 sites with 2:1 randomization) suggests BD is pursuing a comprehensive data package aimed at securing definitive FDA approval rather than a label. This approach indicates confidence in the technology's efficacy for this specific application.
From a market perspective, this positions BD to potentially capture significant share in the breast revision surgery segment, where few evidence-based options currently exist for CC prevention. The multinational, multi-center approach with recognized investigators also demonstrates commitment to generating persuasive clinical evidence required for both regulatory approval and market adoption.
While this clinical trial milestone is positive, investors should understand its place in BD's broader financial picture. The GalaFLEX LITE™ trial represents a pipeline advancement in BD's Surgery business segment, though any revenue impact remains years away pending successful trial completion and FDA approval.
This expansion into breast implant complication management aligns with BD's strategic focus on high-value procedural solutions. The breast implant revision market represents a consistent, recession-resistant revenue opportunity given the 10-20% complication rate in a procedure performed hundreds of thousands of times annually in the US alone.
Importantly, this leverages BD's existing P4HB technology platform rather than requiring entirely new development, suggesting favorable R&D efficiency. The product would likely command premium pricing as an evidence-based solution to a persistent surgical complication.
From a competitive standpoint, securing the first FDA-approved solution specifically for capsular contracture prevention would create a defensible market position and potential reimbursement advantage. However, investors should anticipate at least 2-3 years before potential approval and commercialization, with initial sales likely representing an incremental rather than transformative revenue contribution to BD's
Implant-based breast surgery is among the most common plastic surgery procedures performed each year in the
"This milestone marks a significant advancement in our efforts to achieve FDA Premarket Approval for our first breast indication for GalaFLEX LITE™ Scaffold and reinforces the company's commitment to improving patient outcomes through innovative technologies that reduce surgical complications," said Rian Seger, worldwide president of the BD Surgery business. "Our team has worked closely with the FDA to help address a critical medical complication arising from implant-based breast surgery, and the first patient treated brings us closer to delivering a much-needed solution."
GalaFLEX LITE™ Scaffold is engineered to conform to the desired anatomical structure and provide immediate strength and stability throughout the wound healing period7. It is made from P4HB, a fully absorbable, biologically-derived polymer with more than 10 years of clinical use supporting hernia repair and other plastic and reconstructive procedures where soft tissue weakness or deficiency exists.
"Participating in this trial underscores our commitment to innovation and providing the best evidence-based care for patients suffering from capsular contracture, offering them hope and solutions for the future," said Dr. Shawna Kleban, the board-certified plastic surgeon who performed the inaugural procedure. "This trial allows participants to help identify a solution for themselves and for future patients."
Dr. Caroline Glicksman, the study's National Principal Investigator from
The following five sites are currently enrolling patients:
- HKB Cosmetic Surgery (Various Locations,
North Carolina ) – Principal Investigator: Dr. Bill Kortesis; Sub-Investigators: Dr. Gaurav Bharti, Dr. Shawna Kleban, Dr. Brett Baker - Billington Plastic Surgery (
St. Petersburg, Florida ) – Principal Investigator: Dr. Alicia Billington - The Practice Plastic Surgery (
Beverly Hills, California ) – Principal Investigator: Dr. Kelly Killeen; Sub-Investigator: Dr. Lisa Cassileth - Plastic Surgery Institute of
New York (New York, New York ) – Principal Investigator: Dr. Matthew DelMauro; Sub-Investigator: Dr. Adam Shaffner - Newport Plastic and Reconstructive Surgery Associates (
Newport Beach, California ) – Principal Investigator: Dr. Hisham Seify - Essential Medical Research (
Tulsa, Oklahoma ) – Principal Investigator: Dr. John Tedesco
The trial is expected to enroll at least 250 patients across 40 investigative sites and aims to demonstrate the device's safety and efficacy in breast implant revision surgery to treat capsular contracture. BD is committed to scientific rigor and patient safety and aims to continue proactive FDA engagement in developing products that enhance women's health care.
STANCE Study
STANCE (NCT05945329) Study 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).
About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its more than 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/, X (formerly Twitter) @BDandCo or Instagram @becton_dickinson.
Forward-Looking Statements
This press release contains certain forward-looking statements regarding the Premarket Approval clinical trial for GalaFLEX LITE™ Scaffold. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements, including, without limitation, clinical trial outcomes and progress, obtaining regulatory clearance and approval, including achieving FDA Premarket Approval for the first breast indication for GalaFLEX LITE™ Scaffold, competitive factors, including the development of new technologies or products by other companies, changes in healthcare practices and patient preferences, future regulatory and market conditions, or other factors listed in BD's 2024 Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. BD expressly disclaims any undertaking to update any forward-looking statements set forth herein to reflect events or circumstances after the date hereof, except as required by applicable laws or regulations.
References
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Preclinical data on file. Results may not correlate to clinical outcomes.
For more information about GalaFLEX LITE™ scaffold, please visit www.galateasurgical.com.
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SOURCE BD (Becton, Dickinson and Company)
FAQ
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