BOSTON, Mass. — Encora Therapeutics said the U.S. Food and Drug Administration has granted 510(k) clearance for the Encora X1, a prescription-only wearable device designed to help relieve hand tremors in adults with essential tremor.
The clearance allows Encora to commercially market the Encora X1 as a wrist-worn, noninvasive neurostimulation device intended to reduce tremor in the treated limb during stimulation. The company said the authorization is supported by data from two clinical studies, including a randomized, sham-controlled trial and a 90-day home-use study.
According to Encora, the studies demonstrated consistent improvements in tremor severity and functional tasks, with patients showing better performance in daily activities such as eating, drinking, and writing.
“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 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 roughly the size of a smartwatch and is designed to sense tremor rhythm and deliver customized neurostimulation intended to disrupt tremor signals. The device aims to improve motor stability during everyday activities, including using utensils, dialing a phone, or plugging in an electrical cord.
“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 at Encora Therapeutics. “Encora X1 offers a non-surgical, drug-free alternative, allowing patients to manage their symptoms on their own terms.”
Encora said the clearance represents a key milestone in its development of noninvasive neuromodulation technologies for movement disorders.
“This clearance represents the culmination of rigorous research and patient-centric design,” said Nadim Yared, chief executive officer of Encora Therapeutics. “We are eager to bring this novel solution to patients who have long waited for more options.”
