Pixium Vision announced that the German Institute for the Hospital Remuneration System (InEK) has granted NUB (Neue Untersuchungs- und Behandlungsmethoden) Status-1 for IRIS II, Pixium Vision’s first bionic vision system, equipped with a bioinspired camera and a 150-electrode epiretinal implant with a proprietary design intended to be explantable and upgradable.
The NUB process allows negotiations between hospitals and statutory health insurances on the potential reimbursement of new medical treatments in the German statutory health insurance system (detailed information on the NUB process and Status is available at https://www.g-drg.de/G-DRG-System_2017/Neue_Untersuchungs-_und_Behandlungsmethoden_NUB). Based on NUB Status-1 for IRIS II, ophthalmic hospitals can negotiate reimbursement coverage under the German statutory health insurance system for IRIS II treatment for patients with advanced outer retinal degeneration due to retinitis pigmentosa. A NUB decision is valid for 1 year and can be renewed annually.
"After having received the CE mark for IRIS II, obtaining market access and reimbursement has been the main focus as we continue on our mission towards innovative treatment options," Khalid Ishaque, Chief Executive Officer of Pixium Vision, said in a company news release. "We intend to progressively expand availability across Germany as well as other regions. Obtaining the NUB Status-1 supports our ongoing efforts to bring innovations in bionic vision capabilities to patients blinded by retinal dystrophies.”
The clinical centers offering IRIS II initially include ophthalmic hospitals at the following university clinics:
- Universitätsklinikum Aachen
- Universitätsklinikum Bonn
- Universitätsklinikum Freiburg
- Universitätsklinikum Hamburg-Eppendorf
- Klinikum der Universität München