The company’s epi-retinal implant has 150 electrodes and a bio-inspired camera intended for patients who have lost sight due to retinitis pigmentosa. A computer processes images captured by the camera and transmits the data into a signal, which is then transferred back and projected onto an intraocular implant. The incoming signal stimulates the optic nerve and generates images that the brain can interpret as visual signals.
This status is the highest of 4 levels, and can be renewed annually. Ophthalmic hospitals can negotiate reimbursement coverage under the German statutory health insurance system for Iris II, according to Pixium.
“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,” CEO Khalid Ishaque said in prepared remarks. “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.”
In November, the company reported that the 1st patient in the UK was implanted with its Iris II bionic vision system.
Pixium said the implantation and activation was performed in September by principal investigator Dr. Mahi Muqit at Moorfields Eye Hospital. The procedure was done as a part of Pixium’s ongoing, multi-center clinical trial to evaluate the efficacy of Iris II as a treatment to compensate for blindness and provide greater autonomy for patients.
The company won CE Mark clearance in the European Union for its retinal prosthesis in June last year.