Stockholm, July 1, 2025 – Inossia AB is proud to announce today that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Inossia® Cement Softener for use with PMMA bone cement in percutaneous vertebral augmentation procedures. This is an important step in Inossia’s regulatory plan and supports the planned 510(k) submission.
The FDA’s Breakthrough Device program is reserved for technologies that may significantly improve outcomes for patients with life-threatening or irreversibly debilitating conditions. It offers priority regulatory interaction and accelerated pathways to approval.
Inossia® Cement Softener is indicated to be mixed with an FDA-cleared PMMA bone cement listed in the Instructions for use, in order to adapt its mechanical properties to those of cancellous bone by decreasing its stiffness and strength.
“We see this recognition from the FDA as a strong confirmation of our work and the critical clinical need our product fulfills. This is an important regulatory milestone for us, and we look forward to working closely with the FDA for the 510(k) submission,” says Malin Nilsson, CEO of Inossia AB.
For more information, please visit Inossia at www.inossia.com or contact:
Malin Nilsson, CEO Inossia
E-mail: malin.nilsson@inossia.com
Mobile: +46 (0)702 688674
About Inossia AB
Inossia® develops medical device solutions with a strong focus on active ageing, better treatments and reduced healthcare costs for patients suffering from back pain. Inossia® has invented a softener for bone cement to better treat spinal fractures in osteoporotic patients.
www.inossia.com
