{"id":827867,"date":"2025-03-20T06:53:09","date_gmt":"2025-03-20T10:53:09","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/bd-announces-milestone-in-clinical-trial-for-use-of-bioabsorbable-galaflex-lite-scaffold-in-breast-implant-revision-surgery\/"},"modified":"2025-03-20T06:53:09","modified_gmt":"2025-03-20T10:53:09","slug":"bd-announces-milestone-in-clinical-trial-for-use-of-bioabsorbable-galaflex-lite-scaffold-in-breast-implant-revision-surgery","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/bd-announces-milestone-in-clinical-trial-for-use-of-bioabsorbable-galaflex-lite-scaffold-in-breast-implant-revision-surgery\/","title":{"rendered":"BD Announces Milestone in Clinical Trial for Use of Bioabsorbable GalaFLEX LITE\u2122 Scaffold in Breast Implant Revision Surgery"},"content":{"rendered":"
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PR Newswire<\/p>\n<\/p><\/div>\n

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\n FRANKLIN LAKES, N.J.<\/span>
\n <\/span>, March 20, 2025<\/span><\/span> \/PRNewswire\/ —\u00a0BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the first patient treated in an Investigational Device Exemption (IDE) clinical trial intended to advance BD’s efforts to achieve Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for the use of GalaFLEX LITE\u2122 Scaffold in decreasing capsular contracture (CC) recurrence during breast revision surgery.<\/p>\n

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Implant-based breast surgery is among the most common plastic surgery procedures performed each year in the U.S., and capsular contracture, a condition where the scar tissue naturally forming around the implant becomes unusually hard, causing pain and anatomical displacement, is its most frequent complication, with overall incidence ranging from 10% to 20%1-5<\/sup>. At advanced stages, CC necessitates treatment through surgical intervention, and when performed using conventional techniques, the risk of recurrence may be as high as 54%6<\/sup>. This multi-center Study of GalaFLEX LITE\u2122<\/a> Poly-4-Hydroxybutyrate (P4HB) S<\/u><\/b>caffold in T<\/u><\/b>reatment of Capsular C<\/u><\/b>ontracture after Breast Implant Augmentation (STANCE) is a pivotal study that aims to evaluate whether GalaFLEX LITE\u2122 Scaffold, when used in breast revision surgery, decreases the likelihood of CC and or malposition. The trial further positions BD as a leader in advanced biomaterial science \u2013 driving transformative change in how tissue is reconstructed.<\/p>\n

“This milestone marks a significant advancement in our efforts to achieve FDA Premarket Approval for our first breast indication for GalaFLEX LITE\u2122 Scaffold and reinforces the company’s commitment to improving patient outcomes through innovative technologies that reduce surgical complications,” said Rian Seger,\u00a0worldwide 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.”<\/p>\n

GalaFLEX LITE\u2122 Scaffold is engineered to conform to the desired anatomical structure and provide immediate strength and stability throughout the wound healing period7<\/sup>. 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.<\/p>\n

“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<\/span>, 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.”<\/p>\n

Dr. Caroline Glicksman<\/span>, the study’s National Principal Investigator from Sea Girt, New Jersey<\/span> added, “As an early adopter of the P4HB technology, we are excited to see the potential benefits of GalaFLEX\u2122 LITE Scaffold in improving patient outcomes in breast revision surgeries. This study is crucial in providing the data FDA requires for a specific breast indication that will advance our ability to deliver better solutions for breast surgery patients.”<\/p>\n

The following five sites are currently enrolling patients:<\/p>\n