Biomimetic Innovations gets US-FDA breakthrough device designation for OsStic Synthetic Injectable Structural Bio-Adhesive Bone Void Filler

Biomimetic Innovations Ltd 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 Programme is a voluntary programme for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

The programme 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.

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.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!