Shannon (GLOBE NEWSWIRE) - Biomimetic Innovations Ltd today announced that OsStic® has been granted ‘Breakthrough Device’ designation by the FDA.
The proposed indication statement for this novel new technology is: "OsStic® Synthetic Injectable Bone Void Filler is a structural, mechanically enhanced bioadhesive for reduction, provisional fixation, or void filling of peri-articular fractures or defects to enhance structural stability where standard fixation alone cannot provide sufficient support for functional mobilization."
This Breakthrough Designation of our disruptive technology fuels our passion for earlier mobilization of trauma patients. Paul Burke, Director BMI.
The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. [source]
The program is intended to provide patients and health care providers with timely access to medical devices, by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization. [source]
OsStic® pioneers the evolution of structural orthobiologics, to the point where surgeons can now use this material as an aid for the reduction, provisional fixation and void filling of peri-articular fractures. This is the first calcium phosphate that meets all these clinical requirements. Dr Thomas A Russell, CMO BMI.
Biomimetic Innovations Ltd, is an affiliate of PBC Biomed; a medical device company involved in design, development and manufacturing headquartered in Shannon, Ireland and with offices in Memphis, Tennessee and Chamonix, France.