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]