Encora Therapeutics said the FDA has granted 510(k) clearance for the Encora X1, a small wearable approved for the treatment of hand tremors.
This clearance is supported by data from two clinical studies: a randomized, sham-controlled trial and a 90-day home-use study. Together, these studies demonstrated improvements in tremor severity and functional tasks, showcasing the device's ability to aid in daily activities such as eating, drinking, and writing.
The clearance authorizes the commercial marketing of the Encora X1 as a prescription wearable device to provide relief for adults with essential tremor (ET).
"The data demonstrate meaningful improvement in tremor severity and functional outcomes for patients with limited options,” said Ann Murray, M.D., principal investigator and chief of the WVU Rockefeller Neuroscience Institute (RNI) Comprehensive Movement Disorder Center. “For the 7 million Americans suffering from essential tremor, medications are often ineffective or poorly tolerated, leaving invasive brain therapy as the only alternative. Non-invasive technologies like this represent an important area of innovation in the treatment of essential tremor.”
The Encora X1 is a noninvasive, wrist-worn neurostimulation device, roughly the size of a smart watch, designed to sense tremor rhythm and deliver a customized stimulation that disrupts the tremor signal, providing patients with stability and improved motor control during daily activities, such as drinking soup with a spoon, dialing a telephone, or plugging a cord into an electric outlet.
“We started Encora with a simple goal: to restore independence for movement disorder patients. Today, we are one step closer to making that vision a reality,” said Alli Davanzo, Co-Founder and Vice President of Business Operations. “Encora X1 offers a non-surgical, drug-free alternative, allowing patients to manage their symptoms on their own terms.”
