WASHINGTON and YOQNEAM, Israel, March 22, 2019 /PRNewswire/ -- Neuronix Ltd. announced that the U.S. Food and Drug Administration (FDA) Neurological Devices Advisory Committee met on March 21 to consider data and receive public comment about the neuroAD™ Therapy System, a non-invasive medical device for the treatment of mild-to-moderate Alzheimer's disease.
"We appreciate the thoughtful consideration of the neuroAD data as well as the needs of the Alzheimer's disease community of patients and caregivers. We are pleased that the committee recognized the safety of the device, but we are disappointed that the panel's feedback on our clinical studies and data analysis may result in neuroAD not being available in the US in the foreseeable future. We plan to engage with the FDA to discuss a path forward to ensure that US patients have the same access to this treatment as is enjoyed by Alzheimer's sufferers in over 30 other countries." said Eyal Baror, Neuronix CEO and President. "On a day when yet another Alzheimer's drug trial was curtailed, we believe that this device offers a safe and effective nonpharmacologic solution to patients in need and are appreciative that the committee saw our data as a positive signal toward next steps."
The neuroAD Therapy System is currently approved and available to patients in Europe, Australia and Israel. In the US, the neuroAD Therapy System remains an investigational device and is not yet available. The technology combines transcranial magnetic stimulation (TMS), which stimulates specific cortical brain regions known to be affected by Alzheimer's disease, concurrently with individualized cognitive training exercises aimed to match the same brain regions being stimulated by TMS.
"As a clinician I see patients with Alzheimer's disease every day who are looking for treatment solutions after years of failures in drug development," said Marwan Sabbagh, MD Director of the Cleveland Clinic Lou Ruvo Center for Brain Health. "A device like neuroAD™ Therapy System, that has the potential for improving function and cognition, could provide tangible hope previously and conspicuously missing from the Alzheimer's landscape."
Alzheimer's disease, which affects an estimated 5.7 million Americans of all ages and an estimated 47 million people worldwide, is considered the only leading cause of death that cannot be prevented, cured or even slowed down in progression.
NeuroAD was accepted for review under the Expedited Access Pathway (EAP) program, which is reserved exclusively for medical devices that present novel and breakthrough technologies, and that target an unmet medical need which is life threatening or irreversibly debilitating.
About Neuronix Ltd. and the neuroAD™ Therapy System
Neuronix Ltd. is a privately-owned company, with headquarters in Yoqneam, Israel, and subsidiaries in the US and UK. Neuronix has developed and manufactures novel breakthrough medical-device technology for the treatment of mild-to-moderate Alzheimer's disease. The neuroAD Therapy System is a patent-protected, non-invasive medical device, uniquely combining MRI-scan guided 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.
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SOURCE Neuronix Ltd.