Neuronix submits neuroAD System for FDA clearance

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Neuronix has announced positive results from its pivotal, double-blind placebo-controlled, multicentre clinical study, for the assessment of safety and efficacy of the neuroAD Therapy System, in the treatment of mild to moderate Alzheimer’s disease. Further, Neuronix has filed a US Food and Drug Administration (FDA) de novo application seeking regulatory clearance to market its neuroAD Therapy System for treatment of Alzheimer’s disease. If approved, the neuroAD Therapy System would be the first medical device ever cleared by the FDA for treatment of Alzheimer’s disease.

The neuroAD Therapy System is a patent-protected, non-invasive medical device, uniquely combining transcranial magnetic stimulation (TMS) with cognitive training, to concurrently target brain regions affected by Alzheimer’s disease. This dual-stimulation is designed to improve cognitive performance of patients, following an intervention protocol, which lasts for six weeks, five days per week, with one hour-long session per day.

According to a company release, the study involved 131 patients at nine medical centres in the USA and one in Israel. The study evaluated the safety and efficacy of the neuroAD Therapy System in comparison to placebo, following six weeks of treatment and six weeks of follow-up, using the cognitive and behavioural standard scales for the evaluation of patients with Alzheimer’s disease. The study’s positive outcomes confirm and extend the results of former studies conducted across the world with the neuroAD Therapy System. The detailed results of the study will be presented at the International Conference on Clinical Trials for Alzheimer’s Disease (CTAD; 8–10 December, San Diego, USA).

Based on the study findings, together with the positive results of earlier studies, Neuronix filed an FDA de novo application seeking regulatory clearance to market its neuroAD Therapy System for treatment of Alzheimer’s disease. This submission follows earlier communications with the FDA, as a result of which the neuroAD Therapy System was accepted for review under the Expedited Access Pathway (EAP) programme, which is reserved exclusively for medical devices that present novel and breakthrough technologies, and target an unmet medical need which is life threatening or irreversibly debilitating.

“After years of research and development, and completing several prior successful clinical trials, this recent pivotal multicentre study, which was carried out in some of the most prestigious Alzheimer’s research centres in the world, provides additional evidence that the neuroAD Therapy System offers an important additional potential benefit to patients with Alzheimer’s disease,” says Eyal Baror, CEO of Neuronix. “With these positive findings, we have applied to the FDA for marketing clearance under the EAP program, and expect to have the neuroAD Therapy System cleared in 2017. This will bring new hope for the millions of Alzheimer’s patients and their families who find themselves in a race against time searching for an effective treatment to manage the effects of this debilitating and incurable disease.”

“After seeing the results for myself in patients who have undergone the treatment, I believe that neuroAD is the most exciting breakthrough in the field of Alzheimer’s disease research in more than a decade,” says Alvaro Pascual-Leone, professor of Neurology at Harvard Medical School and chief of the Division of Cognitive Neurology at Beth Israel Deaconess Medical Center, Boston, USA. “While there is still no cure for Alzheimer’s disease, neuroAD is a non-invasive option, with minimal side effects, which has the potential to help patients maintain their cognitive abilities and the independence that so many of us take for granted.”

The neuroAD Therapy System is approved for use in Europe (CE marked 0482), as well as in other territories. It is commercially available in leading Alzheimer’s centres in Europe and Asia. In the United States, the neuroAD Therapy System is an experimental device and is not available for sale.