The device is designed as a structural, mechanically enhanced bioadhesive to help in the reduction, provisional fixation, or void filling of peri-articular fractures or defects
Biomimetic Innovations secures FDA breakthrough device designation for its OsStic filler. (Credit: valelopardo from Pixabay)
Irish medical device company Biomimetic Innovations has secured the breakthrough device designation for its OsStic synthetic injectable structural bio-adhesive bone void filler from the US Food and Drug Administration (FDA).
The device is designed as a structural, mechanically enhanced bioadhesive to assist in the reduction, provisional fixation, or void filling of peri-articular fractures or defects. It aims to bolster structural stability in scenarios where traditional fixation does not suit functional mobilisation, said the company, which is an affiliate of PBC Biomed.
Biomimetic Innovations director Paul Burke said: “This Breakthrough Designation of our disruptive technology fuels our passion for earlier mobilisation of trauma patients.”
The breakthrough devices programme, a voluntary initiative for certain medical devices and device-led combination products, targets to enhance treatment or diagnosis of life-threatening or irreversibly debilitating conditions.
The programme seeks to expedite the availability of these medical devices to patients and healthcare providers by accelerating their development, evaluation, and review processes for premarket approval, 510(k) clearance, and De Novo marketing authorisation.
According to Biomimetic Innovations, OsStic technology has been developed to augment the body’s innate healing mechanisms through the use of biomimetic agents. Presently, this technology is under investigation for its potential applications in both soft and hard tissue repair, spanning human and veterinary medicine, aiming to overcome existing challenges in surgical practices.
Biomimetic Innovations CMO Thomas Russell said: “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.”