OSSIO marked the U.S. launch and first commercial uses of the OSSIOfiber™ Bone Pin, a technology that leaves no permanent hardware behind following repair. Additional procedures are planned in limited markets in coming weeks, with full launch throughout the U.S. in 3Q19.
OSSIOfiber is designed to provide maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis and bone grafts. Initial applications are addressing foot/ankle conditions, and OSSIO plans to pursue use in the distal extremity, trauma, sports medicine, reconstruction, pediatric and spine segments.
Since gaining FDA 510(k) clearance in 1Q19, the company has progressed through milestones such as a $22MM financing and completion of enrollment in a hammertoe clinical trial in Europe that will support CE Mark application in 2020.