Integrum (publ) announced that the company has held a pre-submission meeting with the US Food and Drug Administration (FDA) to discuss the regulatory pathway for the use of Integrum's OPRA Implant System in transhumeral amputations. Based on the conclusions from the meeting, Integrum plans to submit a Pre-Market Approval (PMA) application based on existing clinical data. Since December 2020, the OPRATM Implant System holds a PMA for the treatment of transfemoral (above-knee) amputations.

As the OPRATM Implant System is equally functional in transhumeral (above-elbow) amputations, Integrum aims to broaden the regulatory approval in the US. After a recent pre-submission meeting held with the FDA and additional internal analysis and dialogue with the FDA, Integrum has reason to believe that existing clinical data on the transhumeral (above elbow) amputation level may be sufficient to qualify for a PMA. Integrum will therefore intensify the work to compile and submit a PMA application within the first half of 2024.