BOSTON — Encora Therapeutics announced that its FDA-cleared wearable device, Encora X1, is now available for order through the U.S. Department of Veterans Affairs (VA), expanding non-drug treatment options for veterans living with essential tremor.
More than 30,000 veterans receiving VA care were diagnosed with essential tremor during a single year, according to a peer-reviewed national analysis of VA health records.
Essential tremor is a common movement disorder affecting an estimated 7.6 million Americans. The condition causes involuntary, rhythmic shaking, particularly in the hands, making everyday activities such as eating, drinking, writing and using a phone difficult.
Although medications are typically the first line of treatment, they are not effective for everyone, and side effects can limit their use.
Encora X1 is a wrist-worn device approximately the size of a smartwatch that delivers gentle mechanical neurostimulation to peripheral nerves at the wrist. The device is designed to reduce hand tremors during use and can be worn throughout the day, either independently or alongside existing medications.
“Too many veterans with essential tremor have learned to adapt their lives around their tremor. They use two hands to hold a cup, avoid certain foods, or let someone else pour,” said Daniel Carballo, co-founder of Encora Therapeutics.
“Making Encora X1 available through the VA gives veterans and their care teams another option when medication isn’t enough, isn’t well tolerated, or simply isn’t the right fit, and when they’re looking for an option that isn’t a drug and isn’t a procedure,” Carballo added.
Unlike electrical stimulation devices, Encora X1 uses mechanical stimulation, which the company says makes it an option for patients with implanted electrical devices, including pacemakers.
In clinical studies, improvements were observed within approximately 15 minutes of use. In a randomized, double-blind, sham-controlled study, 70% to 75% of participants experienced a one-point improvement in tremor-related disability after 30 minutes of stimulation, compared with 48% in the sham group.
The company also reported that 96% of study participants described the therapy as comfortable throughout use.
Encora X1 is available to VA facilities through Lovell Government Services, a service-disabled veteran-owned small business responsible for processing orders.
The prescription-only device is available to veterans following consultation with their VA healthcare providers.
