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.
“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 OPRATM 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 OPRATM Implant System as quickly as possible to improve the lives of even more amputees,” says Rickard Brånemark, CEO of Integrum.
For more information, please contact:
Rickard Brånemark, CEO
Phone: +46 (0) 70 846 10 61
Jörgen Svanström, CFO
Phone: + 46 (0) 70 734 96 60
Erik Penser Bank is Certified Adviser.