Organ Preservation for Solid Organ Transplantation

OxyRx may be added to perfusion fluids that are used in a machine perfusion machine (device) in solid organ preservation (typically liver or kidney) prior to transplantation. The addition of OxyRx to organ machine perfusion will improve overall transplant survival, individual transplant function and allow more organs to be transplanted.

This is an ex-vivo usage and constitutes a Device registration & accelerated pathway. Further clinical studies will be required for usage of HPAOC in pre-transplantation and post transplantation where Oxyglobin infusion could be given to transplant recipients.

Regulatory approval for ex vivo use is targeted within 24 months, with the potential for expedited clearance via the Humanitarian Device Exemption (HDE) program.