Integrum plans to submit a PMA application to the FDA for the use of OPRA in transhumeral amputations based on existing clinical data

Mölndal, Sweden – November 13, 2023 — Integrum (publ) (Nasdaq First North Growth Market: INTEG B) today announces 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 OPRA^TM Implant System holds a PMA for the treatment of transfemoral (above-knee) amputations. As the OPRA^TM 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.

“Based on our analysis after the FDA pre-submission meeting, we believe that by gathering existing clinical data, we have sufficient material to submit a PMA application for the use of the OPRA^TM Implant System in transhumeral amputations. This means that the time to a potential market approval will most likely be dramatically reduced, without any need to finance further clinical studies. We now aim to broaden the use of the OPRA^TM Implant System as quickly as possible to improve the lives of even more amputees,” says Rickard Brånemark, CEO of Integrum.