Biomimetic Innovations has recently revealed that the FDA has granted its innovative OsStic® the coveted 'Breakthrough Device' designation. This designation signifies a significant milestone in the field of orthobiologics. The proposed indication for OsStic® describes it as a synthetic injectable bone void filler designed to provide structural support, enhance stability, and aid in the reduction, provisional fixation, or filling of peri-articular fractures or defects.
The Breakthrough Devices Program is a voluntary initiative aimed at expediting the development, assessment, and review processes for medical devices and device-led combination products that address life-threatening or irreversibly debilitating diseases or conditions. This program facilitates quicker access to medical innovations for patients and healthcare providers by streamlining regulatory procedures such as premarket approval, 510(k) clearance, and De Novo marketing authorization.
OsStic® represents a pioneering advancement in structural orthobiologics, allowing surgeons to utilize a novel calcium phosphate solution for various orthopedic applications. Its versatility and clinical efficacy make it a promising option for addressing the challenges associated with peri-articular fractures and defects. This breakthrough underscores Biomimetic Innovations' commitment to advancing orthopedic care and improving patient outcomes.
Source: https://www.globenewswire.com/news-release/2024/01/19/2812393/0/en/FDA-grants-global-Medical-Device-company-Biomimetic-Innovations-Breakthrough-Device-designation-for-OsStic-Synthetic-Injectable-Structural-Bio-Adhesive-Bone-Void-Filler.html
