BD advances trial for breast surgery device

FRANKLIN LAKES, N.J. - BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology firm with a market capitalization of $66.56 billion and annual revenue of $20.64 billion, announced today the commencement of a clinical trial for GalaFLEX LITE™ Scaffold, a device aimed at reducing capsular contracture recurrence in breast revision surgeries. This step moves the company closer to obtaining Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA). According to InvestingPro analysis, BD currently trades below its Fair Value, suggesting potential upside opportunity for investors interested in the healthcare equipment sector.

Capsular contracture, characterized by the hardening of scar tissue around a breast implant, is a common complication post-surgery, affecting 10% to 20% of cases. The IDE (Investigational Device Exemption) clinical trial, named STANCE, will evaluate the safety and efficacy of GalaFLEX LITE™ Scaffold in revision surgeries. The device is designed to conform to anatomical structures, providing strength and stability during the healing process, and is made from a fully absorbable polymer, P4HB, with a decade of clinical use in various reconstructive procedures. As a prominent player in the Healthcare Equipment & Supplies industry with an "GOOD" financial health rating from InvestingPro, BD continues to demonstrate its commitment to innovation and growth.

The trial, involving at least 250 patients across 40 sites, will compare outcomes between patients receiving the GalaFLEX LITE™ Scaffold and those undergoing conventional revision surgery without supportive matrices. It is a randomized, controlled, multi-center study with a 2:1 randomization favoring the new device.

Rian Seger, worldwide president of the BD Surgery business, highlighted this milestone as a significant step in the company’s commitment to enhancing patient outcomes with innovative technologies. Dr. Shawna Kleban, who performed the first procedure, and Dr. Caroline Glicksman, the study’s National Principal Investigator, both emphasized the potential of GalaFLEX LITE™ Scaffold to improve care for patients experiencing capsular contracture.

The trial is currently enrolling patients at five sites, including HKB Cosmetic Surgery in North Carolina, Billington Plastic Surgery in Florida, The Practice Plastic Surgery in California, Plastic Surgery Institute of New York, and Newport Plastic and Reconstructive Surgery Associates in California, along with Essential Medical Research in Oklahoma.

This news is based on a press release statement and aims to provide a balanced view without endorsing any claims. The outcome of the clinical trial and FDA approval processes are yet to be determined and are subject to rigorous evaluation. For investors seeking deeper insights into BD’s financial health and growth prospects, InvestingPro offers comprehensive analysis through its Pro Research Report, including 12+ additional ProTips and extensive financial metrics that help evaluate the company’s investment potential.

In other recent news, BD (Becton, Dickinson and Company) has announced the separation of its Biosciences and Diagnostic Solutions business, a strategic move aimed at enhancing growth and shareholder value. The company’s board has unanimously approved the plan, which is expected to position both BD and the separated entity for success in their respective fields. Additionally, activist investor Starboard Value has acquired a stake in BD, pushing for the sale of the life sciences division, though the specifics of the investment remain undisclosed.

In corporate governance developments, BD’s shareholders have approved all board nominees and ratified Ernst & Young as the independent auditor for fiscal year 2025. The company has also declared a quarterly dividend of $1.04 per share and authorized the repurchase of up to 10 million shares, reflecting confidence in its long-term value. Piper Sandler has raised its price target for BD shares to $280, maintaining an Overweight rating, and has suggested that a spin-off of the Life Sciences division could unlock additional shareholder value.

These recent developments underscore BD’s strategic focus on optimizing its business operations and enhancing shareholder returns.

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