The Center for Devices and Radiological Health at the Food & Drug Administration has determined that Bonalive® Orthopedics granules, made of a unique S53P4 bioactive glass, qualifies for designation as a Breakthrough Device. Proposed indications for use include filling of bony voids and gaps, and potentially protecting against microbial colonization while the granules resorb and are replaced with bone during the healing process.

“With antimicrobial resistance (AMR) increasing worldwide, efforts are required to find new ways of coping with microbial infections. We are very pleased that our proposed indications for use meet the FDA criteria for designation as a Breakthrough Device.”
Dr. Fredrik Ollila Chairman and Founder of Bonalive Biomaterials Ltd.

The goal of the Breakthrough Devices Program is to provide patients and health care providers with access to medical devices that have the potential to provide more effective treatment for life-threatening or irreversibly debilitating diseases or conditions by speeding up their development, assessment, and review, while preserving the statutory standards consistent with the Agency’s mission to protect and promote public health.

Source: Company Press Release