The OSTEOCONFIRM study “Multicenter Prospective Randomized Study of MaioRegen Prime vs. Debridement” (SSOC) is now officially open for patient recruitment.

We are thrilled to announce an extraordinary milestone: the official launch of the IDE (Investigational Device Exemption) clinical trial for our osteochondral substitute

At Fin-Ceramica Faenza S.p.A., we believe that innovation is not just about carving a path, but about redefining the standards of care to tangibly improve patients' quality of life.

Today, we are thrilled to announce an extraordinary milestone: the official launch of the IDE (Investigational Device Exemption) clinical trial for our osteochondral substitute.

The trial aims to demonstrate the superiority of MaioRegen Prime over surgical standard of care (debridement) for the treatment of osteochondral defects, in the knee joints.

307 patients across up to 20 sites in the United States* and Europe are going to be enrolled in the study, supporting US PMA submission targeted for 2030. Up to now 6 highly qualified sites have been activated (5 in US and 1 in Italy) and several additional sites are progressing in both US and Europe to complete the panel.

This milestone not only represents a clinical validation, but also confirms our positioning as a global key player in regenerative medicine.

We are proud to celebrate with you this important achievement, which marks a significant step forward in our mission to advance regenerative medicine and bring innovative solutions to patients worldwide.

*In the United States the MaioRegen implant is not available for sale - it is an investigational device limited for use in the IDE study.