Ossio announced today that it received the third FDA clearance for its OssioFiber product family in recent months.
Woburn, Massachusetts-based Ossio’s latest regulatory nod covers the OssioFiber suture anchors (4.75 mm-5.5 mm) for use in the fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist and elbow in a variety of specific orthopedic procedures.
According to a news release, Ossio intends to initiate the U.S. launch of the OssioFiber suture anchors sometime in the second quarter of 2022.
Today’s announcement is the most recent in a series of regulatory victories for the OssioFiber intelligent bone regeneration technology product line, with OssioFiber compression staples winning FDA clearance in January 2022 and the OssioFiber compression screws garnering the same nod in December 2021. Ossio plans to launch both product lines in the third quarter of this year.
All Ossio implants include the OssioFiber intelligent bone regeneration technology designed to combine mechanical strength and natural bone healing in a non-permanent implant made from a proprietary mineral fiber matrix held together by a naturally degradable polymer. The company said its bio-integrative material properties offer surgeons a more biologically friendly way to restore patient stability and mobility while leaving nothing permanent behind.
The company said the three recent FDA clearances mean it will double the size of its commercial product portfolio, increasing surgeon and patient access to what it calls its “all-natural” treatment options.
“With more than 6,000 implantations of OssioFiber products performed to date, we have already achieved considerable momentum and market penetration in the United States, demonstrating meaningful adoption of our novel, innovative and proprietary orthopedic fixation technology,” Ossio CEO Brian Verrier said in the release. “Naturally, we’re thrilled with the demand for OssioFiber implants—and with these recent FDA clearances, we expect additional uptake of our growing portfolio of bio-integrative products, bringing further clinical and economic benefits to more patients, surgeons, providers and payors.”