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This FDA Investigational Device Exemption (IDE) trial aims to evaluate the effectiveness of the GalaFlex Lite scaffold in reducing the recurrence of capsular contracture (CC) in breast reconstruction surgery. BD Medical hopes that the results of this trial will advance its efforts to obtain premarket approval (PMA) from the FDA, thereby benefiting more patients.

BD Medical stated that this critical study not only evaluates the potential of the GalaFlex Lite scaffold in reducing the risk of CC and/or displacement but also further solidifies the company's leadership in the field of advanced biomaterials science. The GalaFlex Lite scaffold is designed to conform to the required anatomical structure and provide immediate strength and stability during the wound healing process, which is essential for the success of breast implant repair surgeries.

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As a leading company in the field of biomedical engineering, BD has been committed to the research and promotion of innovative medical technologies to improve the quality of life for patients. The successful application of the GalaFlex Lite bioabsorbable breast support system not only demonstrates BD's profound expertise in biomaterials science but also brings new treatment options and hope for breast implant repair surgeries.

In the future, BD will continue to increase its R&D investment in the field of bioabsorbable materials, promoting the development of more innovative products to contribute greater strength to global patient well-being.