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Becton, Dickinson and Company BDX, popularly known as BD, recently announced the first patient treated under an Investigational Device Exemption, aiming to secure FDA Premarket Approval for its GalaFLEX LITE Scaffold. The trial focuses on evaluating the scaffold's ability to reduce the recurrence of capsular contracture (“CC”) in breast revision surgeries.
By advancing this innovative solution, BD is working to address unmet needs in breast reconstruction procedures. The trial reflects the company’s commitment to developing advanced surgical materials that can improve patient recovery, safety and satisfaction.
Likely Trend of the BDX Stock Following the News
Following the announcement, shares of the company closed flat at $230.23 on Friday. In the past six months, BDX’s shares have lost 2.8% compared with the industry’s 2.8% growth. The S&P 500 lost 0.8% in the same time frame.
However, this news could boost the BDX stock in the long run as this shows the company is innovating in a growing surgical market. If the GalaFLEX LITE scaffold proves successful, it can lead to higher demand from surgeons and hospitals seeking better patient outcomes in breast surgeries. This could open up a new revenue stream, strengthen BD’s position in advanced surgical materials and improve profitability over time, all of which can positively influence investor confidence and the stock price.
Meanwhile, BDX currently has a market capitalization of $66.11 billion. The company delivered an earnings surprise of 15.1% in the last reported quarter.
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Details on BDX’s STANCE Study
Implant-based breast surgeries are among the most common plastic surgeries in the United States, with CC being the leading complication, affecting 10% to 20% of patients. CC occurs when scar tissue around the implant hardens, causing pain and implant displacement, often requiring revision surgery with a high risk of recurrence.
BD’s pivotal STANCE study evaluates whether the bioabsorbable GalaFLEX LITE Scaffold can reduce CC recurrence and implant malposition compared with standard revision surgery without a supportive matrix. The randomized, multi-center trial will enroll at least 250 patients across 40 sites, with a 2:1 ratio of patients receiving the scaffold versus standard care, aiming to demonstrate its safety and effectiveness in improving surgical outcomes.
More on BD’s GalaFLEX LITE Scaffold
GalaFLEX LITE Scaffold is an advanced, bioabsorbable surgical mesh, which is designed to provide temporary support to soft tissue during the healing process. Made from P4HB, a naturally derived polymer, the scaffold gradually dissolves in the body over time, leaving behind strengthened, regenerated tissue. It is specifically engineered to be lightweight yet strong, offering the necessary reinforcement without adding long-term foreign material.