Medical Device News

The Audiogene trial is designed to evaluate the safety, tolerability and efficacy of intra-cochlear injection of SENS-501 for the treatment of OTOF gene-mediated hearing loss in paediatric patients aged between 6 and 31 months at the time of gene therapy treatment. By targeting the first years of life, when brain plasticity is at its peak, the chances of these young children with pre-linguistic hearing loss of acquiring normal speech and language are maximised. The trial is comprised of two cohorts of two doses followed by an expansion cohort at the selected dose.

This article gives an overview of the new clinical trial regulations, explaining how key changes will impact clinical research, and how this new accelerated access to clinical innovation will ultimately impact patient care.

“Neuropathy is incredibly common among the aging population, regardless of disease states. There is currently no known cure for neuropathy, and most treatments address acute symptoms with no lasting impact,” says Dr. Ramona von Leden, VP of Research and Clinical Affairs for NeuFit. “NeuFit’s specialized approach to rehab focuses on supporting the function of the nervous system, and we are seeing remarkable results on patients with neuropathy.”