BD - Earth day 2024

FDA Grants Breakthrough Designation to Biomimetic's OsStic® Bone Void Filler

Saturday, January 20, 2024

Biomimetic Innovations Ltd announced today that its product, OsStic®, has received the 'Breakthrough Device' designation from the FDA. The proposed indication statement for this innovative technology states that "OsStic® Synthetic Injectable Bone Void Filler is a bioadhesive with structural and mechanical enhancements. It is designed for the reduction, provisional fixation, or filling of peri-articular fractures or defects to enhance structural stability in cases where standard fixation alone may not offer sufficient support for functional mobilization." This Breakthrough Designation for OsStic® underscores the company's commitment to enabling earlier mobilization of trauma patients.

The Breakthrough Devices Program is a voluntary initiative for specific medical devices and device-led combination products that aim to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. The program expedites the development, assessment, and review processes for premarket approval, 510(k) clearance, and De Novo marketing authorization, ensuring timely access to medical devices for patients and healthcare providers.

OsStic® signifies a significant step in the evolution of structural orthobiologics, allowing surgeons to utilize it for reduction, provisional fixation, and void filling in peri-articular fractures. This breakthrough designation reflects the potential impact of OsStic® on improving patient care and treatment outcomes, providing an innovative solution for cases where standard fixation alone falls short. The progress of OsStic® through further evaluation and regulatory processes will be closely monitored as it holds promise for enhancing clinical practices.


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