Healthcare Industry News: FDA
News Release - February 16, 2022
Bonalive(R) Biomaterials Ltd. Granted FDA Breakthrough Device Designation for a Bone Graft Substitute that Potentially Protects Against Microbial Colonization
TURKU, Finland, Feb. 16, 2022 -- (Healthcare Sales & Marketing Network) -- 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.
About Bonalive Biomaterials Ltd.
Bonalive Biomaterials Ltd. is a Finnish company that produces bone regenerative solutions. The clinical use of S53P4 bioactive glass is supported by a thirty-year history of research and more than 200 peer reviewed publications. Bonalive® products are available in the US, Europe, the Middle East, Asia-Pacific, Africa and South America. www.bonalive.com
About TriMed Bonalive Inc.
Bonalive® Orthopedics granules (K191274) is distributed in the US by TriMed Bonalive Inc., a joint venture company between TriMed Inc. and Bonalive Biomaterials Ltd., headquartered in Santa Clarita, CA. www.trimedortho.com
Source: Bonalive Biomaterials
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