We are starting 2026 with the achievement of an official manufacturing approval for our round window niche implant (RNI)!
Why is this so important? Our RNIs fall within the scope of highly regulated medicinal products. Only with the manufacturing license can we test our RNIs in an initial clinical study.
The competent authority certifies our GMP (Good Manufacturing Practice) compliant production and grants us permission to manufacture our individualized drug-releasing implants for the treatment of inner ear disorders using 3D printing – the green light to apply for the clinical trial (Phase Ib/II) .
The clinical trial is intended to confirm that our RNIs are safe and that the active ingredients they contain reach the inner ear from the middle ear and can thus be detected in the perilymph (inner ear fluid). In addition, the anti-inflammatory effect of our RNIs in cochlear implant patients will be investigated.
The trial aims to prove that our implants can deliver active ingredients locally to hard-to-reach areas of the body, enabling effective therapy with low drug doses and thus fewer side effects.
We are proud to be one step closer to our vision of effective personalized therapy for sudden hearing loss.
Sincere thanks to our partners at MHH and our sponsors. We look forward to taking the next step together!